Device and method for bone adjustment operating with wireless transmission energy

ABSTRACT

A method and a device for bone adjustment in a mammal is presented, wherein a device is implanted in the body of said mammal, said device being a device exerting a force to anchoring devices anchored in said bone. The method and device has utility in therapeutic and cosmetic bone adjustments, including the lengthening, reshaping and realigning of bones, joints or vertebra, for example in the correction of congenital deformations, restorative orthopaedic surgery and the like.

This application is the U.S. national phase of International ApplicationNo. PCT/SE2009/051233 filed 29 Oct. 2009 which designates the U.S. andclaims priority to SE 0802153-7 filed 31 Oct. 2008, and claims thebenefit of U.S. 61/227,808 filed 23 Jul. 2009, the entire contents ofeach of which are hereby incorporated by reference.

FIELD OF THE INVENTION

The present invention concerns methods and devices for therapeutic andcosmetic bone adjustment, and in particular implanted devices, such asbut not limited to implanted hydraulic devices, for adjusting theposition, length, strength or function of bones in the human or animalbody.

BACKGROUND

The art of immobilizing a fractured bone in order to promote healing hasbeen practiced for centuries. Starting from simple splints and sometimesrather unsanitary bandages, the invention of the plaster cast started anew era of orthopaedic medicine. Today, the heavy plaster casts aregradually replaced by lighter fibre glass alternatives. Further, inaddition to purely external splints and casts, a variety of internalsupport structures are widely used. Such support structures includesplints affixed directly to the fractured bone, pins and screws used tohold parts of the bone together during healing and to strengthen thesite of the fracture. Further examples include plates, perforatedscaffolds, intramedullar pins and screws, etc. These can be made of aninert material, such as titan, ceramic, or surgical steel, or made froma material which is resorbed or integrated in the body. Alternatively,the support structure is surgically removed when the fracture is fullyhealed.

Another group of devices, particularly relevant for the presentinvention, are mechanical devices which are mainly situated outside thebody, but which engage the bones inside the body. The simplest form ofsuch devices is a splint in the shape of a metal rod on the outside ofthe body, fixed to pins or screws anchored in the bone, and protrudingthrough the skin. More complicated apparatuses include means foradjusting the position of the bones, for example applying tension to thefracture in order to align a complicated fracture, promote healing or toinduce bone lengthening, a technique called distraction osteogenesis.

One example of external devices or fixtures for bone lengthening orreshaping is the so called Ilizarov apparatus, originally developed inthe 1950s in the Sovjet Union, and introduced in Europe in the 1980s. Insummary, this is an external fixture attached to the bone through theskin and tissues of the patient, and used in a surgical procedure thatcan be used to lengthen or reshape bones. Fixtures of this type areoften used to treat complex fractures, such as open bone fractures,where conventional treatment techniques cannot always be used. It canalso be used to treat infected non-unions of bones not amenable withother techniques. This and similar fixtures are also used for correctingdeformities. For more information see e.g. Snela et al., 2000.

Another fixture is the Taylor Spatial Frame (TSF), an external fixatorsharing a number of components and features of the Ilizarov apparatus.The TSF is a hexapod device consisting of two rings made of aluminiumconnected together by 6 struts. Each strut can be independentlylengthened or shortened. When the apparatus is connected to a bone bywires or half pins, the attached bone can be manipulated in 6 axes(anterior/posterior, varus/valgus, lengthen/shorten.) Both angulardeformities and translational deformities can be corrected with the TSF.It is used in both adults and children. It is used for the treatment ofacute fractures, mal-unions, non uniona and congenital deformities. Itcan be used on both the upper and lower limbs. Specialised foot ringsare also available for the treatment of complex foot deformities.

Once attached to the bone, the deformity is characterised by studyingthe postoperative x-rays. The angular and translational deformity valuesare then entered into specialised software along with parameters such asthe ring size and initial strut lengths. The software then produces a“prescription” of strut changes that the patient follows. The struts areadjusted every day by the patient. Typically, correction of the bonedeformity will take 3 to 4 weeks. Once the deformity has been corrected,the frame is then left on the leg whilst the bone heals, typically thiswill take 3 to 6 months, depending on the nature and degree ofdeformity.

Apparatuses of this kind may also be used for the lengthening of bones.This procedure consists of an initial surgery, during which the bone issurgically fractured and the ring apparatus is attached. As the patientrecovers, the fractured bone begins to grow together. While the bone isgrowing, the frame is adjusted by means of turning the nuts, thusincreasing the space between two rings. As the rings are connected toopposite sides of the fracture, this adjustment, done daily, moves theslowly healing fracture apart by approximately one millimeter per day.The incremental daily increases result in a considerable lengthening ofthe limb over time. Once the lengthening phase is complete, theapparatus stays on the limb to facilitate healing. The patient can moveabout on crutches and pain is lessened. Once healing is complete, asecond surgery is necessary to remove the ring apparatus. The result isa limb that is significantly longer. Additional surgery may benecessary, in the case of leg lengthening, to lengthen the Achillestendon to accommodate the longer bone length. The major advantage ofthis procedure is that the patient can remain active during theprocedure, as the apparatus provides complete support while the bone isrecovering. Patient activity and well-being is known to acceleraterecovery.

While these external fixtures are minimally invasive (no large incisionsare made) they are not free of complications. Pain is common and can besevere, but is treatable with analgesics. Careful attention to dailycleaning and hygiene is necessary to prevent pin site infection. Othercomplications include swelling and muscle transfixion. The externalfixtures are also bulky, causing inconvenience and attracting unwantedattention in daily life.

There are examples of implantable devices, such as the implantable limblengthening nail driven by a shape memory alloy disclosed in U.S. Pat.No. 5,415,660. This disclosure concerns an intramedullar nail consistingof an inner cylinder and an outer cylinder enclosing a drive meansemploying a shape memory alloy. This cylinder is attached to the bone byproximal and distal interlocking bolts, affixed from the outside of thebone, penetrating the bone, e.g. in the area of the epiphysis and thediaphysis, according to the figures in U.S. Pat. No. 5,415,660.

Another example of the background art is the tibial osteotomy fixationdevice of U.S. Pat. No. 5,827,286, comprising two plate members,telescopically movable in relation to each other, and a ratchetmechanism allowing movement in one direction only. This device isadapted for being attached to the outside of a bone, and affixed withbone screws.

U.S. 2005/0055025 A1 discloses various skeletal implants, connectable tojoints or bones, suggesting a mechanism that initially is very rigid andabsorbs external chock or stress thus protecting for example a graft orfracture during healing. It is suggested that this mechanism thenprogressively allows more movement, as the graft or fracture heals.

EP 0 432 253 discloses an intramedullary nail comprising a proximal anda distal end, and a mechanical, pneumatic, hydraulic, electrical orelectromagnetic drive for rotating a rod inside said nail, forlongitudinally expanding said nail. The nail has securing holes forengaging fastening nails or bolts, to be arranged transversally throughthe bone and intramedullary nail.

U.S. Pat. No. 5,156,605 concerns medical equipment for use inorthopaedics and traumatology, and is in particular directed to drivesystems for a compression-distraction-torsion apparatus. One embodimentconcerns an intramedullary device, fully implantable in a patient'sbone, and including a motor drive, controller and battery functions, aswell as radio frequency or electromagnetic field signals to allow aphysician to adjust the rate and rhythm of distraction from outside thebody. The device is shown anchored to the bone using nails or boltspenetrating the diaphysis and both end portions of the device.

Another problem associated with known devices is that the tension needsto be adjusted daily, either by the patient themselves, or by medicalpersonnel. When the patient has the responsibility for adjusting theapparatus, there is a risk of poor compliance, due to pain orpsychological discomfort.

Further, as there are indications that intermittent loading (Consolo etal., 2006), cyclic distraction and compression (Hente et al., 2004) andeven oscillating forces promote osteogenesis and the differentiation ofosteoblasts (Gabbay, 2006), the traditional mechanical devices leaveroom for improvements.

One objective of the present invention is to overcome the problemsassociated with known external and internal mechanical fixtures andsplints.

Another objective is to make available new methods and devices fortreatments involving distractive osteogenesis, both for therapeutic andcosmetic purposes.

Further objectives of the invention, as well as advantages associatedwith embodiments of the invention will become evident to a skilledperson upon a closer study of the present description, non-limitingexamples, claims and drawings.

SUMMARY

The inventions concern an implantable device for the adjustment of abone in a mammal, comprising at least one elongated device adapted to beimplanted in relation to said bone, wherein said device for theadjustment of a bone further comprises an adjustment device foradjusting at least one mechanical bone related parameter of said atleast one elongated device, wherein said adjustment device isconstructed to postoperatively adjust said mechanical bone relatedparameter, and wherein said implantable device for the adjustment of abone is adapted to be wirelessly powered, directly or indirectly, andadapted to receive wireless energy, non-invasively transmitted from anexternal source for adjusting said at least one mechanical bone relatedparameter by said adjustment device.

In a device according to an embodiment of the invention, said mechanicalbone related parameter is related to the lengthening of a bone, theshortening of a bone, the healing of a fracture, the changing of a boneangle, the rotation of a bone, the adjustment of the curvature ortorsion of a bone, the reshaping of a bone, the realignment orrepositioning of a joint or a vertebra, the reforming or supporting theshape of the spinal column, or a combination thereof.

According to another embodiment, said mechanical bone related parametercomprises at least one of: bringing at least two bone-parts defining afracture closer to each other for a period of time having a beneficialinfluence on the initiation of the healing process, and bringing said atleast two bone-parts defining a fracture away from each other for aperiod of time having a beneficial influence on the formation of bone,during the healing process.

For a better understanding of the field, a non-exclusive list ofexamples is given in Table 1 below. It is conceived that the device andmethod according to the invention can be applied by a skilled person toany of these, given that the necessary modifications with regard tosize, force and location are made. Such modifications however appear tobe within the realm of a skilled person without an inventive effort.

Table 1. Examples of Conditions Contemplated as Possible to Treat with aDevice and Method According to the Invention

-   -   Congenital deformities (birth defects), such as congenital short        femur; fibular hemimelia (absence of the fibula, which is one of        the two bones between the knee and the ankle); hemiatrophy        (atrophy of half of the body); and Ollier's disease (also known        as multiple endochondromatosis, dyschondroplasia, and        endochondromatosis).    -   Developmental deformities, such as neurofibromatosis (a rare        condition which causes overgrowth in one leg); and bow legs,        resulting from rickets (rachitis) or secondary arthritis.    -   Post-traumatic injuries, such as growth plates fractures;        malunion or non-union (when bones do not completely join, or        join in a faulty position after a fracture); shortening and        deformity; and bone defects.    -   Infections and diseases, such as osteomyelitis (a bone        infection, usually caused by bacteria); septic arthritis        (infections or bacterial arthritis); and poliomyelitis (a viral        disease which may result in the atrophy of muscles, causing        permanent deformity).    -   Reconstruction after removal of tumours.    -   Short stature, such as achondroplasia (a form of dwarfism where        arms and legs are very short, but torso is more normal in size);        and constitutional short stature.

According to a further embodiment of the inventions, two or moreanchoring devices are adapted to engage the bone from the outsidethereof.

According to another embodiment, two or more anchoring devices areadapted to engage the cortical part of the bone.

According to another embodiment, said two or more anchoring devices areadapted to engage the bone from the inside of the intramedullar cavity.

According to another embodiment, said at least two anchoring devices arechosen from a pin, a screw, an adhesive, a barb construction, asaw-tooth construction, an expandable element, combinations thereof orother mechanical connecting members.

According to a further embodiment, the force exerted by the adjustmentdevice is a longitudinal force, extending the length of the bone.

According to an embodiment, said force exerted by the adjustment deviceis directed to the end portions of the medullar cavity.

According to an embodiment, said the force exerted by the adjustmentdevice is a longitudinal force, adjusting the angle or curvature of thebone.

According to an embodiment, said the force exerted by the device appliestorque to the bone, adjusting the torsion of the bone along it'slongitudinal axis.

According to yet another embodiment, freely combinable with any of theembodiments presented herein, said device is flexible to allowintroduction into the medullar cavity.

According to an embodiment, said device is at least partly elastic.

According to an embodiment, said device comprises a spring.

According to an embodiment, said device regains its shape after havingbeen bent.

According to yet another embodiment, freely combinable with any of theembodiments presented herein, said the anchoring device is adapted to beadjustable by said adjustment device, when implanted in the mammal, forengaging and stabilizing the anchoring device in relation to the bone.

According to an embodiment, the anchoring device comprises a thread forengaging and stabilizing said anchoring device in relation to the bone.

According to another embodiment, the anchoring device comprises anexpandable part expanding at least partially perpendicular to thelongitudinal extension of the elongated device for engaging andstabilizing the anchoring device in relation to the bone

According to another embodiment, the adjustment device comprises ahydraulic device for said bone adjustment, to control the amount offorce exerted by the device onto said anchoring devices.

According to an embodiment, said hydraulic device comprises a cylinderand piston.

According to an embodiment, said hydraulic device comprises a mechanicalmulti step locking mechanism, locking the hydraulic device in its newposition after adjustment.

According to an embodiment, said mechanical multi step locking mechanismcomprises at least one of a sprint, a elongated structure using theprinciple of saw teeth, flanges, barbs or a bonnet band, a nut, agearbox, or a spring loaded locking principle.

According to an embodiment, said hydraulic device comprises hydraulicfluid and a reservoir containing said fluid, adapted to move said fluidto said adjustment device.

According to an embodiment, said hydraulic fluid is moved from saidreservoir to said adjustment device by using a pre-pressurized reservoiror a pump.

According to an embodiment, said hydraulic device comprising a devicepositioning system such as a fluid volume or flow measurement or anyother sensor input to see the position of the adjustment device.

According to another embodiment, freely combinable with any of theembodiments presented herein, said the device comprises a controldevice.

According to an embodiment, said control device follows a program ofincremental changes, set before the device is implanted.

According to an embodiment, said control device follows a program ofincremental changes, communicated to the control device afterimplantation and/or during the treatment.

According to an embodiment, said control device comprises an externalcontrol unit and an implantable receiver suitable for wirelesscommunication with said external control unit, having a transmitterlocated outside the body.

According to an embodiment, said control device controls incrementalchanges of the adjustment device, communicated to the receiver afterimplantation and/or during the treatment by using said external controlunit.

According to an embodiment, said hydraulic adjustment device is adaptedto being stabilized when the bone adjustment is completed.

According to an embodiment, said hydraulic adjustment device can befilled with a material which stabilizes the position of the adjustmentdevice and permanents the distance between the anchoring devices.

In the above embodiment, said material is preferably chosen from curablefoam, a curable gel, a polymer or polymer mixture which solidifies,crosslinks or otherwise attains and retains a stable volume.

According to an embodiment, said hydraulic fluid used in said device isa material chosen from a curable foam, a curable gel, a polymer orpolymer mixture which solidifies, crosslinks or otherwise attains andretains a stable volume when the curing, solidification, crosslinking orother reaction is initiated by the user.

In the above embodiment, the material chosen from a curable foam, acurable gel, a polymer or polymer mixture which solidifies, crosslinksor otherwise attains and retains a stable volume, is added to thedevice, partially or completely replacing the hydraulic fluid.

According to an embodiment, said adjustment device comprises amechanical device for said bone adjustment.

According to an embodiment, said adjustment device is operated by anoperation device, such as motor.

According to a further embodiment, said device comprises a controldevice, wherein the operation device is controlled by said controldevice.

According to a further embodiment, the motor comprising a motor ordevice positioning system such as a tachometer or any other sensor inputto see the position of the adjustment device.

According to a further embodiment, the mechanical device for said boneadjustment comprises at least one nut and screw.

According to a further embodiment, the mechanical device for said boneadjustment comprises at least one gearbox.

According to a further embodiment, the mechanical device for said boneadjustment comprises a servo mechanism or mechanical amplifier.

According to a further embodiment, said device is adapted for exertingan intermittent and/or oscillating force.

According to an embodiment, said hydraulic device comprises a mechanicalmulti step locking mechanism, locking the hydraulic device in its newposition after adjustment.

According to an embodiment, said mechanical multi step locking mechanismcomprises at least one of a sprint, a elongated structure using theprinciple of saw teeth, flanges, barbs or a bonnet band, a nut, agearbox, or a spring loaded locking principle.

The inventions also concern a method for bone adjustment in a mammal,wherein a hydraulic or mechanical device according to any of the abovepresented embodiments is used and implanted in the body of said mammal.

According to a further embodiment, said device is implantedintramedullary in the body of said mammal, exerting a force to anchoringdevices anchored to the inside of said bone.

According to a further embodiment, said bone adjustment is thelengthening of a bone, the healing of a fracture, the changing of a boneangle, the reshaping of a bone, or a combination thereof.

According to a further embodiment, said adjustment is a step in atreatment to correct a limb discrepancy caused by a congenitalcondition, deformation or previous trauma.

According to a further embodiment, said adjustment is reshaping orlengthening of a bone involving distraction osteogenesis treatment.

According to a further embodiment, said adjustment is the reshaping orlengthening of a bone as a step of correcting a congenital deformation.

According to a further embodiment, said adjustment is the reshaping orlengthening of a bone as a step of a cosmetic treatment.

According to another embodiment of the method, freely combinable withany of the embodiments presented herein, reshaping is one of changingthe angle or curvature of a bone, changing the torsion of a bone,changing the angle between the diaphysis and the epiphysis, changing thethickness of a bone or a combination thereof.

According to another embodiment a device is implanted intramedullary inthe body of said mammal, wherein said device is a hydraulic deviceexerting a force to anchoring devices anchored in said bone and acontrol device which controls the amount of force exerted by the device.

According to another embodiment a device is implanted intramedullary inthe body of said mammal, wherein said device is a mechanical deviceexerting a force to anchoring devices anchored in said bone and acontrol device which controls the amount of force exerted by the device.

According to another embodiment of the method, freely combinable withany of the embodiments presented herein, said control device follows aprogram of incremental changes, set before the device is implanted.Alternatively, said control device follows a program of incrementalchanges, communicated to the control device after implantation and/orduring the treatment.

According to another embodiment of the method, freely combinable withany of the embodiments presented herein, the device is stabilized whenthe treatment is completed.

According to an embodiment, said device is stabilized by filling thedevice with a material which stabilizes the position of the adjustmentdevice and permanents the distance between the anchoring devices.Preferably said material is chosen from curable foam, a curable gel, apolymer or polymer mixture which solidifies, crosslinks or otherwiseattains and retains a stable volume.

According to another embodiment said device is a hydraulic device andthe hydraulic fluid is a material chosen from a curable foam, a curablegel, a polymer or polymer mixture which solidifies, crosslinks orotherwise attains and retains a stable volume when the curing,solidification, crosslinking or other reaction is initiated by the user.

According to another embodiment, the device is a hydraulic device and amaterial chosen from curable foam, a curable gel, a polymer or polymermixture which solidifies, crosslinks or otherwise attains and retains astable volume, is added to said device, partially or completelyreplacing the hydraulic fluid.

Another embodiment comprises a method for distractive osteogenesis wherethe fractured bone is subjected to an intermittent and/or oscillatingforce using an implanted hydraulic or mechanical device.

Another embodiment is a method for treating a bone dysfunction of amammal patient by providing a device for bone adjustment comprising atleast two anchoring devices according to any of the embodimentspresented herein, the method comprising the steps of

-   -   i. inserting a needle or tube-like instrument into a cavity of        said mammal patient;    -   ii. inflating said cavity by introducing a fluid through said        needle or tube-like instrument and thereby expanding said        cavity;    -   iii. placing at least two laparoscopic trocars in said cavity;    -   iv. inserting a camera through one of said laparoscopic trocars        into said cavity;    -   v. inserting at least one dissecting tool through one of said at        least two laparoscopic trocars;    -   vi. dissecting an area of the dysfunctional bone;    -   vii. placing the device for bone adjustment and anchoring        devices in the medullar cavity of said bone;    -   viii. anchoring said anchoring devices in contact with said        bone;    -   ix. closing the mammal body preferably in layers; and    -   x. non-invasively adjusting said bone postoperatively.

Another embodiment is method of treating a bone dysfunction of a mammalpatient by providing a device for bone adjustment comprising at leasttwo anchoring devices according to any of the embodiments presentedherein, comprising the steps of:

-   -   i. cutting the skin of said human patient;    -   ii. dissecting an area of the dysfunctional bone;    -   iii. placing the device in the medullar cavity of said bone;    -   iv. anchoring said anchoring devices in contact with said bone;    -   v. closing the mammal body preferably in layers; and    -   vi. non-invasively adjusting said bone postoperatively.

The method according to any of the above embodiments preferablycomprises the step of withdrawing the instruments.

The method according to any of the above embodiments preferablycomprises the step of closing the skin using sutures or staples.

According to a further embodiment of the method, the step of dissectingincludes dissecting an area of the arm or leg comprising, dissecting anarea of at least one of the following bones; clavicula, scapula,humerus, radius, ulna, pelvic bone, femur, tibia, fibula or calcaneus.

According to a further embodiment of the method, the step of dissectingincludes dissecting an area of the arm or leg comprising, dissecting anarea at least one of the following joints; shoulder, elbow, hip, knee,hand and foot.

According to a further embodiment of the method, an opening into themedullar cavity is made by drilling.

The inventions also concern a system comprising an apparatus accordingto any one of the embodiments presented herein.

According to a further embodiment of the system, said system comprisesat least one switch implantable in the patient for manually andnon-invasively controlling the apparatus.

According to another embodiment, said system further comprises ahydraulic device having an implantable hydraulic reservoir, which ishydraulically connected to the apparatus, wherein the apparatus isadapted to be non-invasively regulated by manually pressing thehydraulic reservoir.

According to another embodiment, said system further comprises awireless remote control for non-invasively controlling the apparatus.

According to another embodiment, the wireless remote control comprisesat least one external signal transmitter and/or receiver, furthercomprising an internal signal receiver and/or transmitter implantable inthe patient for receiving signals transmitted by the external signaltransmitter or transmitting signals to the external signal receiver.

According to another embodiment, said wireless remote control transmitsat least one wireless control signal for controlling the apparatus.

According to another embodiment, said wireless control signal comprisesa frequency, amplitude, or phase modulated signal or a combinationthereof.

According to another embodiment, said wireless remote control transmitsan electromagnetic carrier wave signal for carrying the control signal.

According to another embodiment, said system further comprises awireless energy-transmission device for non-invasively energizingimplantable energy consuming components of the apparatus with wirelessenergy.

According to another embodiment, said wireless energy comprises a wavesignal selected from the following: a sound wave signal, an ultrasoundwave signal, an electromagnetic wave signal, an infrared light signal, avisible light signal, an ultra violet light signal, a laser lightsignal, a micro wave signal, a radio wave signal, an x-ray radiationsignal and a gamma radiation signal.

According to another embodiment, said wireless energy comprises one ofthe following: an electric field, a magnetic field, a combined electricand magnetic field.

According to another embodiment, said control signal comprises one ofthe following: an electric field, a magnetic field, a combined electricand magnetic field.

According to another embodiment, said signal comprises an analoguesignal, a digital signal, or a combination of an analogue and digitalsignal.

According to another embodiment, said system further comprises animplantable internal energy source for powering implantable energyconsuming components of the apparatus.

According to another embodiment, said system further comprises anexternal energy source for transferring energy in a wireless mode,wherein the internal energy source is chargeable by the energytransferred in the wireless mode.

According to another embodiment, said system further comprises a sensoror measuring device sensing or measuring a functional parametercorrelated to the transfer of energy for charging the internal energysource, and a feedback device for sending feedback information frominside the patient's body to the outside thereof, the feedbackinformation being related to the functional parameter sensed by thesensor or measured by the measuring device.

According to another embodiment, said system further comprises afeedback device for sending feedback information from inside thepatient's body to the outside thereof, the feedback information beingrelated to at least one of a physical parameter of the patient and afunctional parameter related to the apparatus.

According to another embodiment, said system further comprises a sensorand/or a measuring device and an implantable internal control unit forcontrolling the apparatus in response to information being related to atleast one of a physical parameter of the patient sensed by the sensor ormeasured by the measuring device and a functional parameter related tothe apparatus sensed by the sensor or measured by the measuring device.Said physical parameter is preferably a pressure or a motility movement.

According to another embodiment, said system further comprises anexternal data communicator and an implantable internal data communicatorcommunicating with the external data communicator, wherein the internalcommunicator feeds data related to the apparatus or the patient to theexternal data communicator and/or the external data communicator feedsdata to the internal data communicator.

According to another embodiment, said system further comprises a motoror a pump for operating the apparatus.

According to another embodiment, said system further comprises ahydraulic operation device for operating the apparatus.

According to another embodiment, said system further comprises anoperation device for operating the apparatus, wherein the operationdevice comprises a servo or mechanical amplifier designed to decreasethe force needed for the operation device to operate the apparatusinstead the operation device acting a longer way, increasing the timefor a determined action.

According to another embodiment, said system further comprises anoperation device for operating the apparatus, wherein the wirelessenergy is used in its wireless state to directly power the operationdevice to create kinetic energy for the operation of the apparatus, asthe wireless energy is being transmitted by the energy-transmissiondevice.

According to another embodiment, said system further comprises anenergy-transforming device for transforming the wireless energytransmitted by the energy-transmission device from a first form into asecond form of energy.

According to an embodiment said energy-transforming device directlypowers implantable energy consuming components of the apparatus with thesecond form energy, as the energy-transforming device transforms thefirst form energy transmitted by the energy-transmission device into thesecond form energy.

According to an embodiment said second form energy comprises at leastone of a direct current, pulsating direct current and an alternatingcurrent.

According to another embodiment, said system further comprises animplantable accumulator, wherein the second form energy is used at leastpartly to charge the accumulator.

According to an embodiment, freely combinable with any of theembodiments presented herein, said energy of the first or second formcomprises at least one of magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy thermal energy, non-magnetic energy, non-kinetic energy,non-chemical energy, non-sonic energy, non-nuclear energy andnon-thermal energy.

According to another embodiment, said system further comprisesimplantable electrical components including at least one voltage levelguard and/or at least one constant current guard.

According to another embodiment, said system further comprises a controldevice for controlling the transmission of wireless energy from theenergy-transmission device, and an implantable internal energy receiverfor receiving the transmitted wireless energy, the internal energyreceiver being connected to implantable energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto, the system further comprising a determination device adapted todetermine an energy balance between the energy received by the internalenergy receiver and the energy used for the implantable energy consumingcomponents of the apparatus, wherein the control device controls thetransmission of wireless energy from the external energy-transmissiondevice, based on the energy balance determined by the determinationdevice.

According to an embodiment, said determination device is adapted todetect a change in the energy balance, and the control device controlsthe transmission of wireless energy based on the detected energy balancechange.

According to another embodiment, said determination device is adapted todetect a difference between energy received by the internal energyreceiver and energy used for the implantable energy consuming componentsof the apparatus, and the control device controls the transmission ofwireless energy based on the detected energy difference.

According to another embodiment, said energy-transmission devicecomprises a coil placed externally to the human body, further comprisingan implantable energy receiver to be placed internally in the human bodyand an electric circuit connected to power the external coil withelectrical pulses to transmit the wireless energy, the electrical pulseshaving leading and trailing edges, the electric circuit adapted to varyfirst time intervals between successive leading and trailing edgesand/or second time intervals between successive trailing and leadingedges of the electrical pulses to vary the power of the transmittedwireless energy, the energy receiver receiving the transmitted wirelessenergy having a varied power.

According to another embodiment, said electric circuit is adapted todeliver the electrical pulses to remain unchanged except varying thefirst and/or second time intervals.

According to another embodiment, said the electric circuit has a timeconstant and is adapted to vary the first and second time intervals onlyin the range of the first time constant, so that when the lengths of thefirst and/or second time intervals are varied, the transmitted powerover the coil is varied.

According to another embodiment, said system further comprises animplantable internal energy receiver for receiving wireless energy, theenergy receiver having an internal first coil and a first electroniccircuit connected to the first coil, and an external energy transmitterfor transmitting wireless energy, the energy transmitter having anexternal second coil and a second electronic circuit connected to thesecond coil, wherein the external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver, the system further comprising a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off.

According to another embodiment, said system further comprises animplantable internal energy receiver for receiving wireless energy, theenergy receiver having an internal first coil and a first electroniccircuit connected to the first coil, and an external energy transmitterfor transmitting wireless energy, the energy transmitter having anexternal second coil and a second electronic circuit connected to thesecond coil, wherein the external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver, the system further comprising a feedback device forcommunicating out the amount of energy received in the first coil as afeedback information, and wherein the second electronic circuit includesa determination device for receiving the feedback information and forcomparing the amount of transferred energy by the second coil with thefeedback information related to the amount of energy received in thefirst coil to obtain the coupling factors between the first and secondcoils.

According to another embodiment, said transmitted energy may beregulated depending on the obtained coupling factor.

According to another embodiment, said external second coil is adapted tobe moved in relation to the internal first coil to establish the optimalplacement of the second coil, in which the coupling factor is maximized.

According to another embodiment, said external second coil is adapted tocalibrate the amount of transferred energy to achieve the feedbackinformation in the determination device, before the coupling factor ismaximized.

According to another embodiment, said mechanical device comprises amechanical multi step locking mechanism, locking the mechanical devicein its new position after adjustment.

According to a further embodiment, said mechanical multi step lockingmechanism comprises at least one of a sprint, a elongated structureusing the principle of saw teeth, flanges, barbs or a bonnet band, anut, a gearbox, or a spring loaded locking principle.

According to an embodiment, said hydraulic adjustment device is adaptedto being stabilized when the bone adjustment is completed.

According to an embodiment, said hydraulic adjustment device can befilled with a material which stabilizes the position of the adjustmentdevice and permanents the distance between the anchoring devices.

In the above embodiment, said material is preferably chosen from curablefoam, a curable gel, a polymer or polymer mixture which solidifies,crosslinks or otherwise attains and retains a stable volume.

According to an embodiment, said hydraulic fluid used in said device isa material chosen from a curable foam, a curable gel, a polymer orpolymer mixture which solidifies, crosslinks or otherwise attains andretains a stable volume when the curing, solidification, crosslinking orother reaction is initiated by the user.

In the above embodiment, the material chosen from a curable foam, acurable gel, a polymer or polymer mixture which solidifies, crosslinksor otherwise attains and retains a stable volume, is added to thedevice, partially or completely replacing the hydraulic fluid.

According to another embodiment, said device comprises a control device.Said control device preferably follows a program of incremental changes,set before the device is implanted. Alternatively, said control devicefollows a program of incremental changes, communicated to the controldevice after implantation and/or during the treatment.

According to an embodiment, said control device comprises an externalcontrol unit and an implantable receiver suitable for wirelesscommunication with said external control unit, having a transmitterlocated outside the body.

According to another embodiment, said control device controlsincremental changes of the adjustment device, communicated to thereceiver after implantation and/or during the treatment by using saidexternal control unit.

According to another embodiment, freely combinable with any otherembodiment presented herein, said adjustment device is adapted to adjusttorsion of a bone.

According to another embodiment, said adjustment device is adapted tochange the angle of a bone.

According to another embodiment, said adjustment device comprises atleast two parts, wherein the parts is adapted to rotate in relation toeach other.

According to another embodiment, said relative rotation is anchored bysaid at least two anchoring devices.

According to another embodiment, said adjustment device comprises atleast two parts, wherein the parts is adapted to be angled in relationto each other.

According to another embodiment, said adjustment device is adapted tochange the curvature of a bone including the spinal column.

According to another embodiment, said adjustment device is adapted torealign or reposition a joint or a vertebra including the reforming orsupporting the shape of the spinal column.

According to another embodiment, two or more anchoring devices areadapted to engage and carry weight purely on the outside of the bone.

According to another embodiment of the device, said two or moreanchoring devices are adapted to engage with and carry weight to thebone without penetrating to the inside of the bone, the medulla of thebone.

According to another embodiment, said adjustment device is adapted to beplaced on the outside of the bone.

According to yet another embodiment, said device comprises a sensordirect or indirect sensing the position of the adjustment device.

According to yet another embodiment, said device comprises a feedbacktransmitter adapted to transmit information received direct or indirectfrom said sensor out from the human body, said transmitted informationadapted to be received by a external control unit and relating to theposition of the adjustment device.

According to an embodiment, said operation device is a motor operated asa three-phase motor. Alternatively, said operation device is a motoroperated as a two- or more phase motor.

According to yet another embodiment, said device comprises a gearboxconnected to the motor, a motor package, wherein the outgoing speed fromthe motor package is lower than the speed by said motor alone,accomplished by said gearbox.

According to a further embodiment, said outgoing speed of the motor insaid motor package is decreased by said electrical speed controller.

According to an embodiment, said motor is a rotational motor and theoutgoing speed of the motor package is decreased to less than 100 turnsper second, or decreased to less than 10 turns per second, or to lessthan 1 turn per second, or to less than 0.1 turn per second, or to lessthan 0.01 turn per second, or to less than 0.001 turn per second.

According to yet another embodiment, said device comprises an electricalspeed controller connected to the motor, a motor package, wherein theoutgoing speed of the motor in said motor package is controlled by saidelectrical speed controller.

According to an embodiment, said motor is a linear motor and theoutgoing speed of the motor package is less than 1 mm per second, orless than 0.1 mm per second, or less than 0.01 mm per second, or lessthan 0.001 mm per second, or less than 0.0001 mm per second, or lessthan 0.00001 mm per second.

SHORT DESCRIPTION OF THE DRAWINGS

The invention will be disclosed in further detail in the followingdescription, examples and claims, with reference to the attacheddrawings in which

FIG. 1 (Prior art) shows an intramedullar device or internalautodistractor according to U.S. Pat. No. 5,156,605, inserted into theintramedullar cavity of a femur through an opening A in the epiphysis.The device is anchored by a pair of interlocking screws B at the top ofthe assembly, and by a pair of interlocking bolts C which will passthrough the bottom of the assembly, and secure it to the femur.

FIG. 2 (Prior art) shows an intramedullar pin or “medullar nail”according to EP 432 253 B1, also published as WO 91/00065, havingsecuring holes E and D and a mechanical, pneumatic, hydraulic,electrical or electromagnetic drive for rotating the rod for thelongitudinal displacement of an inner portion thereof.

FIG. 3 (Prior art) schematically shows an external fixator (1) of thetype frequently referred to as an Ilizarov apparatus, here consisting oftwo rings (2, 3) having pins (4) attached to and stabilizing the tibiaor fibula in the lower leg (5) of a patient. The distance between therings (2, 3) of the fixator (1) can be adjusted by manually turningthreaded cylinders (6, 7, 8) on struts connecting the rings.

FIG. 4 shows one embodiment of the invention where two implanted devicesare arranged to a bone.

FIG. 5 shows a detailed view of a device for bone adjustment accordingto an embodiment of the invention.

FIG. 6 schematically shows a device according to an embodiment of theinventions, implanted into the medullar cavity of a bone.

FIGS. 7a and 7b show detail views of devices according to embodiments ofthe invention.

FIG. 8 shows in detail 8 a a schematic lateral view of the human spine,columna vertebralis (500) and illustrates in the partial views 8 b and 8c how devices according to embodiments of the invention can be applied.

FIGS. 9a and 9b illustrate the straightening of a bone, or how thecurvature of a bone can be adjusted, using devices according toembodiments of the invention.

FIGS. 9c and 9d show how the curvature of a bone, here a femur, can beadjusted using intramedullar devices according to embodiments of theinvention.

FIGS. 9e and 9f illustrate how an intramedullar device can be used toadjust the torsion of a bone, here illustrated as the femur.

FIGS. 10a and 10b show schematically detail views of two devicesaccording to embodiments of the invention, said devices including amechanical multi step locking device.

FIG. 11 schematically illustrates a system for bone adjustment accordingto one embodiment of the invention, described in closer detail in thedetailed description.

FIGS. 12a-12d schematically shows the insertion of a flexible deviceaccording to an embodiment of the invention.

FIGS. 13a-13e illustrate different non-limiting examples of theconstruction of the end-portions of the fastening means or anchoringdevices according to embodiments of the invention.

FIGS. 14-28 schematically show various embodiments of the system forwirelessly powering an apparatus, for example, but not limited to, thoseshown in FIG. 4, 11, 12 and FIG. 38.

FIG. 29 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of theapparatus shown in FIG. 11.

FIG. 30 schematically shows an embodiment of the system, in which theapparatus is operated with wire-bound energy.

FIG. 31 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the apparatus shown in FIG. 11.

FIG. 32 shows a circuit drawing for the arrangement shown in FIG. 27,according to a possible implementation example.

FIG. 33 illustrates anchoring devices according to an embodiment of theinvention.

FIG. 34 illustrates anchoring devices according to another embodiment ofthe invention.

FIG. 35 illustrates an embodiment of the device, comprising twotelescopically arranged parts, housing a longitudinal threaded centralshaft or axis and a motor or gear arrangement acting thereon,transforming rotational force into longitudinal force and extension orcontraction of the device.

FIG. 36 shows a related embodiment where the device comprises three mainparts, a central section, and two telescopically arranged end sections,each connected to a longitudinal threaded central shaft or axis througha motor or gear arrangement.

FIGS. 37A and B show embodiments where a device for bone adjustmentaccording to the present invention is enclosed in a flexible, elastic orexpandable outer cover.

FIG. 38 illustrates an implanted device according to the invention,where the anchoring devices engage the bone from the inside of themedullar cavity.

FIG. 39 shows schematically an embodiment of a device comprising amotor, a gear box and a speed controller.

FIG. 40 schematically shows an embodiment where the implanted adjustmentdevice comprises at least two parts, wherein the parts are adapted to bepositioned at an angle in relation to each other, and/or rotated inrelation to each other.

DETAILED DESCRIPTION

Before the present invention is described, it is to be understood thatthe terminology employed herein is used for the purpose of describingparticular embodiments only and is not intended to be limiting, sincethe scope of the present invention will be limited only by the appendedclaims and equivalents thereof.

It must be noted that, as used in this specification and the appendedclaims, the singular forms “a,” “an,” and “the” include plural referentsunless the context clearly dictates otherwise.

Also, the term “about” is used to indicate a deviation of +/−2% of thegiven value, preferably +/−5%, and most preferably +/−10% of the numericvalues, where applicable.

The term “animal” encompasses all mammals and in particular humans.Similarly, the terms “treatment”, “therapy”, and “therapeutic use”encompass both human and animal or veterinary applications.

The term “extension device” comprises any device which is capable oflongitudinal movement and in particular capable of exerting a forcelongitudinally between two or more points. An extension device can be ahydraulic device, an electronic device, a mechanical device, or acombination of two or more of the previous.

The term “hydraulic device” comprises any device wherein the energy thatbrings about the longitudinal force is transmitted by a hydraulic fluidacting on elements in the device. Examples of such elements include, butare not limited to hydraulic cylinders, hydraulically inflatable tubes,balloons, bellows and the like.

The term “implanted” indicates that a device or an element of a deviceis introduced permanently or temporarily into a human or animal body. Animplanted device can be contained within the human or animal body in itsentirety, or only partially, for example by being accessible through aport or other interface in the skin of said human or animal. Animplanted device can be enclosed in a human or animal body in itsentirety, and communicate wirelessly with an external apparatus fortransmitting and receiving signals, for example transmitting measurementdata and receiving control signals, and for receiving energy.

The inventions concern an implantable device for the adjustment of abone in a mammal, comprising at least one elongated device adapted to beimplanted in relation to said bone, wherein said device for theadjustment of a bone further comprises an adjustment device foradjusting at least one mechanical bone related parameter of said atleast one elongated device, wherein said adjustment device isconstructed to postoperatively adjust said mechanical bone relatedparameter, and wherein said implantable device for the adjustment of abone is adapted to be wirelessly powered, directly or indirectly, andadapted to receive wireless energy, non-invasively transmitted from anexternal source for adjusting said at least one mechanical bone relatedparameter by said adjustment device.

In a device according to an embodiment of the invention, said mechanicalbone related parameter is related to the lengthening of a bone, theshortening of a bone, the healing of a fracture, the changing of a boneangle, the rotation of a bone, the adjustment of the curvature ortorsion of a bone, the reshaping of a bone, the realignment orrepositioning of a joint or a vertebra, the reforming or supporting theshape of the spinal column, or a combination thereof.

According to another embodiment, said mechanical bone related parametercomprises at least one of: bringing at least two bone-parts defining afracture closer to each other for a period of time having a beneficialinfluence on the initiation of the healing process, and bringing said atleast two bone-parts defining a fracture away from each other for aperiod of time having a beneficial influence on the formation of bone,during the healing process.

According to a further embodiment of the inventions, two or moreanchoring devices are adapted to engage the bone from the outsidethereof.

This is illustrated schematically in FIG. 4 where a fractured tibia (10)having a fracture zone (20) is shown, supported by two devices (40, 50)according to the invention, both devices being attached to anchoringdevices (31, 32, 33, 34) attached to the bone.

FIG. 5 shows a detailed view where an extension device, hereschematically shown as a hydraulic device (80) having two actuators (91,92) attached to two anchoring devices (101, 102) which can beconventional pins or screws, suitable for inserting in bone. Thehydraulic device is in fluid contact through a tube (110) to a hydraulicpower unit (120) supplying pressurized hydraulic fluid, which in turncommunicates with a control unit (130). Optionally, said control elementalso supplies the hydraulic power unit with energy. The hydraulic powerunit may comprise a reservoir and a pump or a hydrophore type ofpre-pressurized expansion reservoir or any other hydraulic solution. Thecontrol unit, energy source, reservoir, pump or motor may all beimplanted separate or together in any combination.

The power unit 120 can further be connected to or comprise a hydraulicpump 121 associated with a reservoir 122 containing of a fluid used toregulate the pressure of the device 80. The pump is thus adapted to pumpthe hydraulic fluid in or out from the device 80 in order to adjust thepressure in the device and the position of the actuators 91, 92.

The power unit 120 can also comprise a rechargeable battery 123chargeable from the outside by an external power supply/charger unit 112sending wireless energy.

The adjustment can be controlled by an electronic remote control unit124 adapted to receive and transmit signals from a transmitter/receiver106 located outside the body of a treated patient.

The hydraulic device preferably comprises a device positioning systemsuch as a fluid volume or flow measurement or any other sensor input tosee the position of the adjustment device. A sensor sensing elongation,for example a capacitance sensor or impedance sensor or any sensorsensing movement or a specific position is preferably provided, hereindicated as 125, a sensor communicating with the control unit 124.

Alternatively the schematic FIG. 5 may also instead show a mechanicaldevice 80. In such a case a mechanical wire is outlined as 110 adaptedto operate said mechanical device. The power unit 120 may in such a caseinstead comprise a motor 121 a servo 123 and as before the control unit124 and sensor 125. The rechargeable power supply may instead beindicated by the unit 122. The motor may of course be placed directly inthe mechanical unit 80, wherein the mechanical wire 110 instead is anelectrical wire.

FIG. 6 illustrates an embodiment of the invention, where a device isimplanted in a bone (200), said bone having two end portions orepiphysis (201, 202) and a fracture zone (206), said fracture zone alsoconstituting the growth or elongation zone. The medullar cavity (204) isschematically shown in a partial cut-out view and in said cavity, adevice (210) is provided, said device having actuators or anchoringmeans (212, 214) acting on the end portions of the medullar cavity, thuselongating the bone through osteogenesis in the fracture or elongationzone (206).

Detailed views of the device 210, according to different embodiments ofthe invention are shown in FIG. 7.

FIG. 7a schematically shows an embodiment of an extension element ordevice (300), comprising a housing (301) with an electrical motor (302)acting on a threaded cylinder (303) engaged to two actuators (304, 305).Any mechanical solution may be applied. Preferably the motor uses aservo mechanism to economize force to distance. The control unit, energysource, motor or servo mechanism may all be implanted separately ortogether in any combination.

FIG. 7b schematically shows another embodiment of an extension elementor device (400) comprising a housing (401) with two pistons (402, 403)connected to two actuators (404, 405). The pistons together with thehousing and possible additional elements form a hydraulic device,connected via a tubing (406) to a hydraulic power unit (not shown).

A device according to the invention can also be applied to theadjustment of the curvature of the spine. FIG. 8 illustrates anembodiment where a device according to the invention is applied to theadjustment of the curvature of the spine. Detail (a) is a posterior viewof the vertebrae of the lower back, vertebrae lumbales, schematicallyshowing two devices (501, 504) according to the invention attached toopposite sides of the spine. For illustration purposes, one device (501)is shown attached to two adjoining vertebrae by two anchoring devices(502, 503) anchored in the corpus vertebrae, whereas another device(504) is shown attached to two non-adjoining vertebrae by two anchoringdevices (505, 506). Detail (b) is a lateral detail schematically showingtwo devices (510, 520) according to the invention attached to oppositesides of the spine by anchoring devices (511, 512, 521, 522). Forillustration purposes, one device acts on adjoining vertebrae, whereasthe other device acts on non-adjoining vertebrae. This embodiment can beused to adjust the curvature of the spine, to relieve a herniated lumbardisc or the like.

According to another embodiment, the force exerted by the adjustmentdevice is a longitudinal force, adjusting the angle or curvature of thebone. This is illustrated in FIG. 9a schematically showing a frontalview of the right femur (600) exhibiting a curvature deviating from thenatural form of this bone. The curvature may be due to a congenitaldisease or other condition. The dashed lines (601, 602) indicate how thebone can be fractured, preferably by sawing. In one example, wedgeshaped parts are removed and the bone divided into sections, hereillustrated as three sections. FIG. 9b shows how these three sections ofthe femur (603) are repositioned to a desired orientation, i.e. astraighter bone. The fracture zones (604, 605) are then used as growthzones in order to compensate for the loss of length due to the removalof bone. Devices (606, 607) according to the invention are then attachedvia actuators and anchoring devices to said sections, ensuring theirposition and exerting force to achieve an elongation by distractiveosteogenesis. The arrows illustrate schematically that the parts of thebone can be adjusted in relation to each other, for example by adjustingthe angle or orientation of said parts.

According to another embodiment, two or more anchoring devices areadapted to engage the cortical part of the bone.

According to another embodiment, said two or more anchoring devices areadapted to engage the bone from the inside of the intramedullar cavity.

According to another embodiment, said at least two anchoring devices arechosen from a pin, a screw, an adhesive, a barb construction, asaw-tooth construction, an expandable element, combinations thereof orother mechanical connecting members.

According to a further embodiment, the force exerted by the adjustmentdevice is a longitudinal force, extending the length of the bone.

According to an embodiment, said force exerted by the adjustment deviceis directed to the end portions of the medullar cavity.

According to an embodiment, said the force exerted by the adjustmentdevice is a longitudinal force, adjusting the angle or curvature of thebone.

According to an embodiment, said the force exerted by the device appliestorque to the bone, adjusting the torsion of the bone along itslongitudinal axis.

A related embodiment is illustrated in FIGS. 9c and 9d , where adeformed bone 600 is cut at two locations, 601 and 602, each cutpreferably being wedge shaped in order to allow for the straightening ofthe bone, and devices 610 and 620 according to the inventions insertedinto the medullar cavity. Similarly as in FIG. 9b , the arrowsillustrate schematically that the parts of the bone can be adjusted inrelation to each other, for example by adjusting the angle ororientation of said parts.

According to yet another embodiment, the force exerted by the deviceapplies torque to the bone, adjusting the torsion of the bone along itslongitudinal axis. This embodiment is illustrated in FIGS. 9e and 9f ,where a bone 600 is cut along the dashed line 630 and optionally alongone or more lines, exemplified as 631. One or more implantable device ordevices 640 and 650 according to the invention are inserted into themedullar cavity. The arrows indicate that one or several parts of thebone can be adjusted, for example rotated in relation to a joint, or toa section of the bone.

According to yet another embodiment, freely combinable with any of theembodiments presented herein, said device is flexible to allowintroduction into the medullar cavity.

According to an embodiment, said device is at least partly elastic.

According to an embodiment, said device comprises a spring.

According to an embodiment, said device regains its shape after havingbeen bent.

According to yet another embodiment, freely combinable with any of theembodiments presented herein, said the anchoring device is adapted to beadjustable by said adjustment device, when implanted in the mammal, forengaging and stabilizing the anchoring device in relation to the bone.

According to an embodiment, the anchoring device comprises a thread forengaging and stabilizing said anchoring device in relation to the bone.

According to another embodiment, the anchoring device comprises anexpandable part expanding at least partially perpendicular to thelongitudinal extension of the elongated device for engaging andstabilizing the anchoring device in relation to the bone

According to another embodiment, the adjustment device comprises ahydraulic device for said bone adjustment, to control the amount offorce exerted by the device onto said anchoring devices.

According to an embodiment, said hydraulic device comprises a cylinderand piston.

The advantages of a flexible device are illustrated in FIG. 12a-12dwhich schematically show a bone 200, having a fracture zone I. Anopening II is prepared by a surgeon, allowing the insertion of a deviceIII into the intramedullar cavity IV. FIG. 12b illustrates how thedevice III is flexible according to an embodiment of the invention, andhow this makes it possible to introduce said device into theintramedullar cavity through an opening which is not in straightlongitudinal extension to the cavity. Further, FIG. 12c illustrates howthe device III, when in place in the cavity IV, retains its originalshape and in addition, expands longitudinally to exert a force againstthe end portions of the cavity. The anchoring devices are activated andsecurely engage the surrounding bone. The opening II is preferablyclosed, e.g. using bone cement. Finally, FIG. 12d illustrates anembodiment where the device III is connected to a power unit V, whichcan have the components and functions as the power unit 120 shown inFIG. 5.

FIG. 11 illustrates a system for treating a disease comprising anapparatus 301 according to an embodiment of the present invention placedin the lower leg of a patient. An implanted energy-transforming device302 is adapted to supply energy consuming components of the apparatuswith energy via a power supply line 303. An external energy-transmissiondevice 304 for non-invasively energizing the apparatus 301 transmitsenergy by at least one wireless energy signal. The implantedenergy-transforming device 302 transforms energy from the wirelessenergy signal into electric energy which is supplied via the powersupply line 303. Another external device 305 is illustrated,schematically showing a device capable of transmitting control signalsto the apparatus 301, and optionally receiving signals transmitted bythe apparatus 301, for example information about the position, energylevel, tension, pressure, temperature or other relevant informationregistered by one or more sensors (not shown) included in the apparatus.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 304 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 302 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 304 into energy of a second form, whichtypically is different from the energy of the first form. The implantedapparatus 301 is operable in response to the energy of the second form.The energy-transforming device 302 may directly power the apparatus withthe second form energy, as the energy-transforming device 302 transformsthe first form energy transmitted by the energy-transmission device 304into the second form energy. The system may further include animplantable accumulator, wherein the second form energy is used at leastpartly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 304 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 304. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 304 may beused to directly power the operation device to create kinetic energy forthe operation of the apparatus.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 302 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the apparatus compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the apparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patient's body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 304 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the apparatus.The control signal is received by an implanted signal receiver which maybe incorporated in the implanted energy-transforming device 302 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 14 illustrates the system for example as shown in FIG. 4, FIG. 6,FIG. 12 or FIG. 38 in the form of a more generalized block diagramshowing the implanted apparatus 301, an energy-transforming device 302powering the apparatus 301 via power supply line 303, and the externalenergy-transmission device 304, The patient's skin 305, generally shownby a vertical line, separates the interior of the patient to the rightof the line from the exterior to the left of the line.

FIG. 15 shows an embodiment of the invention identical to that of FIG.14, except that a reversing device in the form of an electric switch 306operable for example by polarized energy also is implanted in thepatient for reversing the apparatus 301. When the switch is operated bypolarized energy the wireless remote control of the externalenergy-transmission device 304 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 302transforms the wireless polarized energy into a polarized current foroperating the electric switch 306. When the polarity of the current isshifted by the implanted energy-transforming device 302 the electricswitch 306 reverses the function performed by the apparatus 301.

FIG. 16 shows an embodiment of the invention identical to that of FIG.14, except that an operation device 307 implanted in the patient foroperating the apparatus 301 is provided between the implantedenergy-transforming device 302 and the apparatus 301. This operationdevice can be in the form of a motor 307, such as an electricservomotor. The motor 307 is powered with energy from the implantedenergy-transforming device 302, as the remote control of the externalenergy-transmission device 304 transmits a wireless signal to thereceiver of the implanted energy-transforming device 302.

FIG. 17 shows an embodiment of the invention identical to that of FIG.14, except that it also comprises an operation device is in the form ofan assembly 308 including a motor/pump unit 309 and a fluid reservoir310 is implanted in the patient. In this case the apparatus 301 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 309 from the fluid reservoir 310 through a conduit 311 to theapparatus 301 to operate the apparatus, and hydraulic fluid is pumped bythe motor/pump unit 309 back from the apparatus 301 to the fluidreservoir 310 to return the apparatus to a starting position. Theimplanted energy-transforming device 302 transforms wireless energy intoa current, for example a polarized current, for powering the motor/pumpunit 309 via an electric power supply line 312.

Instead of a hydraulically operated apparatus 301, it is also envisagedthat the operation device comprises a pneumatic operation device. Inthis case, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 302 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 18 shows an embodiment of the invention comprising the externalenergy-transmission device 304 with its wireless remote control, theapparatus 301, in this case hydraulically operated, and the implantedenergy-transforming device 302, and further comprising a hydraulic fluidreservoir 313, a motor/pump unit 309 and an reversing device in the formof a hydraulic valve shifting device 314, all implanted in the patient.Of course the hydraulic operation could easily be performed by justchanging the pumping direction and the hydraulic valve may therefore beomitted. The remote control may be a device separated from the externalenergy-transmission device or included in the same. The motor of themotor/pump unit 309 is an electric motor. In response to a controlsignal from the wireless remote control of the externalenergy-transmission device 304, the implanted energy-transforming device302 powers the motor/pump unit 309 with energy from the energy carriedby the control signal, whereby the motor/pump unit 309 distributeshydraulic fluid between the hydraulic fluid reservoir 313 and theapparatus 301. The remote control of the external energy-transmissiondevice 304 controls the hydraulic valve shifting device 314 to shift thehydraulic fluid flow direction between one direction in which the fluidis pumped by the motor/pump unit 309 from the hydraulic fluid reservoir313 to the apparatus 301 to operate the apparatus, and another oppositedirection in which the fluid is pumped by the motor/pump unit 309 backfrom the apparatus 301 to the hydraulic fluid reservoir 313 to returnthe apparatus to a starting position.

FIG. 19 shows an embodiment of the invention comprising the externalenergy-transmission device 304 with its wireless remote control, theapparatus 301, the implanted energy-transforming device 302, animplanted internal control unit 315 controlled by the wireless remotecontrol of the external energy-transmission device 304, an implantedaccumulator 316 and an implanted capacitor 317. The internal controlunit 315 arranges storage of electric energy received from the implantedenergy-transforming device 302 in the accumulator 316, which suppliesenergy to the apparatus 301. In response to a control signal from thewireless remote control of the external energy-transmission device 304,the internal control unit 315 either releases electric energy from theaccumulator 316 and transfers the released energy via power lines 318and 319, or directly transfers electric energy from the implantedenergy-transforming device 302 via a power line 320, the capacitor 317,which stabilizes the electric current, a power line 321 and the powerline 319, for the operation of the apparatus 301.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the apparatus 301 according to a pre-programmedtime-schedule or to input from any sensor sensing any possible physicalparameter of the patient or any functional parameter of the system.

In accordance with an alternative, the capacitor 317 in the embodimentof FIG. 19 may be omitted. In accordance with another alternative, theaccumulator 316 in this embodiment may be omitted.

FIG. 20 shows an embodiment of the invention identical to that of FIG.14, except that a battery 322 for supplying energy for the operation ofthe apparatus 301 and an electric switch 323 for switching the operationof the apparatus 301 also are implanted in the patient. The electricswitch 323 may be controlled by the remote control and may also beoperated by the energy supplied by the implanted energy-transformingdevice 302 to switch from an off mode, in which the battery 322 is notin use, to an on mode, in which the battery 322 supplies energy for theoperation of the apparatus 301.

FIG. 21 shows an embodiment of the invention identical to that of FIG.20, except that an internal control unit 315 controllable by thewireless remote control of the external energy-transmission device 304also is implanted in the patient. In this case, the electric switch 323is operated by the energy supplied by the implanted energy-transformingdevice 302 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 315 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 315 to releaseelectric energy from the battery 322 for the operation of the apparatus301.

FIG. 22 shows an embodiment of the invention identical to that of FIG.21, except that an accumulator 316 is substituted for the battery 322and the implanted components are interconnected differently. In thiscase, the accumulator 316 stores energy from the implantedenergy-transforming device 302. In response to a control signal from thewireless remote control of the external energy-transmission device 304,the internal control unit 315 controls the electric switch 323 to switchfrom an off mode, in which the accumulator 316 is not in use, to an onmode, in which the accumulator 316 supplies energy for the operation ofthe apparatus 301. The accumulator may be combined with or replaced by acapacitor.

FIG. 23 shows an embodiment of the invention identical to that of FIG.22, except that a battery 322 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 304, the internal control unit 315 controlsthe accumulator 316 to deliver energy for operating the electric switch323 to switch from an off mode, in which the battery 322 is not in use,to an on mode, in which the battery 322 supplies electric energy for theoperation of the apparatus 301.

Alternatively, the electric switch 323 may be operated by energysupplied by the accumulator 316 to switch from an off mode, in which thewireless remote control is prevented from controlling the battery 322 tosupply electric energy and is not in use, to a standby mode, in whichthe wireless remote control is permitted to control the battery 322 tosupply electric energy for the operation of the apparatus 301.

It should be understood that the switch 323 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

According to an embodiment, said adjustment device comprises amechanical device for said bone adjustment.

According to an embodiment, said adjustment device is operated by anoperation device, such as motor.

According to a further embodiment, said device comprises a controldevice, wherein the operation device is controlled by said controldevice.

According to a further embodiment, the motor comprising a motor ordevice positioning system such as a tachometer or any other sensor inputto see the position of the adjustment device.

According to a further embodiment, the mechanical device for said boneadjustment comprises at least one nut and screw.

According to a further embodiment, the mechanical device for said boneadjustment comprises at least one gearbox.

According to a further embodiment, the mechanical device for said boneadjustment comprises a servo mechanism or mechanical amplifier.

According to a further embodiment, said device is adapted for exertingan intermittent and/or oscillating force.

FIG. 24 shows an embodiment of the invention identical to that of FIG.20, except that a motor 307, a mechanical reversing device in the formof a gear box 324, and an internal control unit 315 for controlling thegear box 324 also are implanted in the patient. The internal controlunit 315 controls the gear box 324 to reverse the function performed bythe apparatus 301 (mechanically operated). Even simpler is to switch thedirection of the motor electronically. The gear box interpreted in itsbroadest embodiment may stand for a servo arrangement saving force forthe operation device in favour of longer stroke to act.

This is also illustrated in FIG. 39 which schematically shows a deviceaccording to an embodiment of the invention where an implantable device2000 comprises a motor 2010 operationally connected to a gear box 2020and an adjustment device 2030, where the speed and/or effect of themotor 2010 is controlled by a control unit 2040.

According to one embodiment, said control unit 2040 both senses thespeed of the motor 2010 and adjusts the same, and optionally also sensesthe output speed of the gear box 2020, driving the adjustment device2030. According to another embodiment, said control unit 2040 comprisesa feed-back loop, sensing the speed o the motor, and adjusting the sameto a desired value. In another embodiment, no gear box is present, andthe control unit 2040 both senses the speed of the motor and adjusts thesame.

FIG. 25 shows an embodiment of the invention identical to that of FIG.23 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 315 is powered by thebattery 322 when the accumulator 316, suitably a capacitor, activatesthe electric switch 323 to switch to an on mode. When the electricswitch 323 is in its on mode the internal control unit 315 is permittedto control the battery 322 to supply, or not supply, energy for theoperation of the apparatus 301.

FIG. 26 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the apparatus 301, the internal control unit 315,motor or pump unit 309, and the external energy-transmission device 304including the external wireless remote control. As already describedabove the wireless remote control transmits a control signal which isreceived by the internal control unit 315, which in turn controls thevarious implanted components of the apparatus.

A feedback device, preferably comprising a sensor or measuring device325, may be implanted in the patient for sensing a physical parameter ofthe patient. The physical parameter may be at least one selected fromthe group consisting of pressure, volume, diameter, stretching,elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysical parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 325 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, pressure, volume, diameter, stretch,elongation, extension, movement, bending, elasticity, temperature andflow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 315, or alternatively the external wirelessremote control of the external energy-transmission device 304, maycontrol the apparatus 301 in response to signals from the sensor 325. Atransceiver may be combined with the sensor 325 for sending informationon the sensed physical parameter to the external wireless remotecontrol. The wireless remote control may comprise a signal transmitteror transceiver and the internal control unit 315 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the internal control unit315 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the apparatus 301 from inside thepatient's body to the outside thereof.

Where the motor/pump unit 309 and battery 322 for powering themotor/pump unit 309 are implanted, information related to the chargingof the battery 322 may be fed back. To be more precise, when charging abattery or accumulator with energy feed back information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 27 shows an alternative embodiment wherein the apparatus 301 isregulated from outside the patient's body. The system 300 comprises abattery 322 connected to the apparatus 301 via a subcutaneous electricswitch 326. Thus, the regulation of the apparatus 301 is performednon-invasively by manually pressing the subcutaneous switch, whereby theoperation of the apparatus 301 is switched on and off. It will beappreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.Two subcutaneous switches may also be used. In the preferred embodimentone implanted switch sends information to the internal control unit toperform a certain predetermined performance and when the patient pressthe switch again the performance is reversed.

FIG. 28 shows an alternative embodiment, wherein the system 300comprises a hydraulic fluid reservoir 313 hydraulically connected to theapparatus. Non-invasive regulation is performed by manually pressing thehydraulic reservoir connected to the apparatus.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to theapparatus or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.

FIG. 29 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patient's body to theoutside thereof to give feedback information related to at least onefunctional parameter of the apparatus or system, or related to aphysical parameter of the patient, in order to supply an accurate amountof energy to an implanted internal energy receiver 302 connected toimplanted energy consuming components of the apparatus 301. Such anenergy receiver 302 may include an energy source and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external energy source 304 a located outside thepatient and is received by the internal energy receiver 302 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentsof the apparatus 301. An energy balance is determined between the energyreceived by the internal energy receiver 302 and the energy used for theapparatus 301, and the transmission of wireless energy is thencontrolled based on the determined energy balance. The energy balancethus provides an accurate indication of the correct amount of energyneeded, which is sufficient to operate the apparatus 301 properly, butwithout causing undue temperature rise.

In FIG. 29 the patient's skin is indicated by a vertical line 305. Here,the energy receiver comprises an energy-transforming device 302 locatedinside the patient, preferably just beneath the patient's skin 305.Generally speaking, the implanted energy-transforming device 302 may beplaced in the abdomen, thorax, muscle fascia (e.g. in the abdominalwall), subcutaneously, or at any other suitable location. The implantedenergy-transforming device 302 is adapted to receive wireless energy Etransmitted from the external energy-source 304 a provided in anexternal energy-transmission device 304 located outside the patient'sskin 305 in the vicinity of the implanted energy-transforming device302.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 304 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 302. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the apparatus, e.g. after storing theincoming energy in an implanted energy source, such as a rechargeablebattery or a capacitor. However, the present invention is generally notlimited to any particular energy transfer technique, TET devices orenergy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 304 b that controls the externalenergy source 304 a based on the determined energy balance to regulatethe amount of transferred energy. In order to transfer the correctamount of energy, the energy balance and the required amount of energyis determined by means of a determination device including an implantedinternal control unit 315 connected to the apparatus 301. The internalcontrol unit 315 may thus be arranged to receive various measurementsobtained by suitable sensors or the like, not shown, measuring certaincharacteristics of the apparatus 301, somehow reflecting the requiredamount of energy needed for proper operation of the apparatus 301.Moreover, the current condition of the patient may also be detected bymeans of suitable measuring devices or sensors, in order to provideparameters reflecting the patient's condition. Hence, suchcharacteristics and/or parameters may be related to the current state ofthe apparatus 301, such as power consumption, operational mode andtemperature, as well as the patient's condition reflected by parameterssuch as; body temperature, blood pressure, heartbeats and breathing.Other kinds of physical parameters of the patient and functionalparameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 316 mayoptionally be connected to the implanted energy-transforming device 302for accumulating received energy for later use by the apparatus 301.Alternatively or additionally, characteristics of such an accumulator,also reflecting the required amount of energy, may be measured as well.The accumulator may be replaced by a rechargeable battery, and themeasured characteristics may be related to the current state of thebattery, any electrical parameter such as energy consumption voltage,temperature, etc. In order to provide sufficient voltage and current tothe apparatus 301, and also to avoid excessive heating, it is clearlyunderstood that the battery should be charged optimally by receiving acorrect amount of energy from the implanted energy-transforming device302, i.e. not too little or too much. The accumulator may also be acapacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 315. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 315 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus 301, or the patient, or an implanted energysource if used, or any combination thereof. The internal control unit315 is further connected to an internal signal transmitter 327, arrangedto transmit a control signal reflecting the determined required amountof energy, to an external signal receiver 304 c connected to theexternal control unit 304 b. The amount of energy transmitted from theexternal energy source 304 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 304 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 304 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 304 b, thus integrating the above-describedfunction of the internal control unit 315 in the external control unit304 b. In that case, the internal control unit 315 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 327 which sends the measurements over to the external signalreceiver 304 c and the external control unit 304 b. The energy balanceand the currently required amount of energy can then be determined bythe external control unit 304 b based on those sensor measurements.

Hence, the present solution according to the arrangement of FIG. 25employs the feedback of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the apparatus. The apparatus may use thereceived energy either for consuming or for storing the energy in animplanted energy source or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance. However, such parameters may alsobe needed per se for any actions taken internally to specificallyoperate the apparatus.

The internal signal transmitter 327 and the external signal receiver 304c may be implemented as separate units using suitable signal transfermeans, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 327 and the externalsignal receiver 304 c may be integrated in the implantedenergy-transforming device 302 and the external energy source 304 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 29, the switch 326is either separate and controlled by the internal control unit 315, orintegrated in the internal control unit 315. It should be understoodthat the switch 326 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 29 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 315 of the determination device.A control signal reflecting the required amount of energy is alsocreated by the internal control unit 315, and the control signal istransmitted from the internal signal transmitter 327 to the externalsignal receiver 304 c. Alternatively, the energy balance can bedetermined by the external control unit 304 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external energy source 304 a can then be regulated bythe external control unit 304 b, based on the determined energy balance,e.g. in response to the received control signal. This process may berepeated intermittently at certain intervals during ongoing energytransfer, or may be executed on a more or less continuous basis duringthe energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 304 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.

This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

This coupling factors information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorsbetween the first and second coils. The transmitted energy may beregulated depending on the obtained coupling factor.

With reference to FIG. 30, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 30,wherein an external switch 326 is interconnected between the externalenergy source 304 a and an operation device, such as an electric motor307 operating the apparatus 301. An external control unit 304 b controlsthe operation of the external switch 326 to effect proper operation ofthe apparatus 301.

FIG. 31 illustrates different embodiments for how received energy can besupplied to and used by the apparatus 301. Similar to the example ofFIG. 29, an internal energy receiver 302 receives wireless energy E froman external energy source 304 a which is controlled by a transmissioncontrol unit 304 b. The internal energy receiver 302 may comprise aconstant voltage circuit, indicated as a dashed box “constant V” in thefigure, for supplying energy at constant voltage to the apparatus 301.The internal energy receiver 302 may further comprise a constant currentcircuit, indicated as a dashed box “constant C” in the figure, forsupplying energy at constant current to the apparatus 301.

The apparatus 301 comprises an energy consuming part 301 a, which may bea motor, pump, restriction device, or any other medical appliance thatrequires energy for its electrical operation. The apparatus 301 mayfurther comprise an energy storage device 301 b for storing energysupplied from the internal energy receiver 302. Thus, the suppliedenergy may be directly consumed by the energy consuming part 301 a, orstored by the energy storage device 301 b, or the supplied energy may bepartly consumed and partly stored. The apparatus 301 may furthercomprise an energy stabilizing unit 301 c for stabilizing the energysupplied from the internal energy receiver 302. Thus, the energy may besupplied in a fluctuating manner such that it may be necessary tostabilize the energy before consumed or stored.

The energy supplied from the internal energy receiver 302 may further beaccumulated and/or stabilized by a separate energy stabilizing unit 328located outside the apparatus 301, before being consumed and/or storedby the apparatus 301. Alternatively, the energy stabilizing unit 328 maybe integrated in the internal energy receiver 302. In either case, theenergy stabilizing unit 328 may comprise a constant voltage circuitand/or a constant current circuit.

It should be noted that FIG. 29 and FIG. 31 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 32 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such change takes place. If the amount of receivedenergy is lower than the energy used by the implant, more energy istransferred and thus charged into the energy source. The output signalfrom the circuit is typically feed to an A/D converter and convertedinto a digital format. The digital information can then be sent to theexternal energy-transmission device allowing it to adjust the level ofthe transmitted energy. Another possibility is to have a completelyanalog system that uses comparators comparing the energy balance levelwith certain maximum and minimum thresholds sending information toexternal energy-transmission device if the balance drifts out of themax/min window.

The schematic FIG. 32 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatus ofthe present invention from outside of the patient's body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, L1, is included in the schematic figure; the transmitting parts ofthe system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 28and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 32 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 306 of FIG. 11 could be incorporated in any of theembodiments of FIGS. 14-20, the hydraulic valve shifting device 314could be incorporated in another embodiment of the inventions, and thegear box 324 could be incorporated in yet another embodiment.

Please observe that the switch simply could mean any electronic circuitor component.

The embodiments described in connection with FIGS. 29, 31 and 32identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming components of an electricallyoperable apparatus. Such a method and system will be defined in generalterms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal energy source located outside the patient and is received by aninternal energy receiver located inside the patient, the internal energyreceiver being connected to the implanted energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto. An energy balance is determined between the energy received bythe internal energy receiver and the energy used for the apparatus. Thetransmission of wireless energy E from the external energy source isthen controlled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physical parameters of the medical device and/orphysical parameters of the patient are determined, the energy may betransmitted for consumption and storage according to a transmission rateper time unit which is determined based on said parameters. The totalamount of transmitted energy may also be determined based on saidparameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising an apparatus as described above is thus alsoprovided for controlling transmission of wireless energy supplied toimplanted energy consuming components of the apparatus. In its broadestsense, the system comprises a control device for controlling thetransmission of wireless energy from an energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the apparatus for directly orindirectly supplying received energy thereto. The system furthercomprises a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theapparatus, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.

Further, the system may comprise any of the following:

-   -   A primary coil in the external energy source adapted to transmit        the wireless energy inductively to a secondary coil in the        internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the apparatus, and the control device controls the transmission        of wireless energy based on the detected energy difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for the apparatus is consumed to operate the        apparatus, and/or stored in at least one energy storage device        of the apparatus.    -   Where electrical and/or physical parameters of the apparatus        and/or physical parameters of the patient are determined, the        energy-transmission device transmits the energy for consumption        and storage according to a transmission rate per time unit which        is determined by the determination device based on said        parameters. The determination device also determines the total        amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

According to an embodiment, said wireless energy comprises a wave signalselected from the following: a sound wave signal, an ultrasound wavesignal, an electromagnetic wave signal, an infrared light signal, avisible light signal, an ultra violet light signal, a laser lightsignal, a micro wave signal, a radio wave signal, an x-ray radiationsignal and a gamma radiation signal.

According to an embodiment, said wireless energy comprises one of thefollowing: an electric field, a magnetic field, a combined electric andmagnetic field.

According to an embodiment, said control signal comprises one of thefollowing: an electric field, a magnetic field, a combined electric andmagnetic field.

According to a further embodiment, said the signal comprises an analoguesignal, a digital signal, or a combination of an analogue and digitalsignal.

According to yet another embodiment, said system further comprises animplantable internal energy source for powering implantable energyconsuming components of the apparatus.

According to yet another embodiment, said system further comprises anexternal energy source for transferring energy in a wireless mode,wherein the internal energy source is chargeable by the energytransferred in the wireless mode.

According to yet another embodiment, said system further comprises asensor or measuring device sensing or measuring a functional parametercorrelated to the transfer of energy for charging the internal energysource, and a feedback device for sending feedback information frominside the patient's body to the outside thereof, the feedbackinformation being related to the functional parameter sensed by thesensor or measured by the measuring device.

According to yet another embodiment, said system further comprises afeedback device for sending feedback information from inside thepatient's body to the outside thereof, the feedback information beingrelated to at least one of a physical parameter of the patient and afunctional parameter related to the apparatus.

According to yet another embodiment, said system further comprises asensor and/or a measuring device and an implantable internal controlunit for controlling the apparatus in response to information beingrelated to at least one of a physical parameter of the patient sensed bythe sensor or measured by the measuring device and a functionalparameter related to the apparatus sensed by the sensor or measured bythe measuring device.

According to another embodiment, said physical parameter is a pressureor a motility movement.

According to yet another embodiment, said system further comprises anexternal data communicator and an implantable internal data communicatorcommunicating with the external data communicator, wherein the internalcommunicator feeds data related to the apparatus or the patient to theexternal data communicator and/or the external data communicator feedsdata to the internal data communicator.

According to yet another embodiment, said system further comprises amotor or a pump for operating the apparatus.

According to yet another embodiment, said system further comprises ahydraulic operation device for operating the apparatus.

According to yet another embodiment, said system further comprises anoperation device for operating the apparatus, wherein the operationdevice comprises a servo designed to decrease the force needed for theoperation device to operate the apparatus instead the operation deviceacting a longer way, increasing the time for a determined action.

According to yet another embodiment, said system further comprises anoperation device for operating the apparatus, wherein the wirelessenergy is used in its wireless state to directly power the operationdevice to create kinetic energy for the operation of the apparatus, asthe wireless energy is being transmitted by the energy-transmissiondevice.

According to yet another embodiment, said system further comprises anenergy-transforming device for transforming the wireless energytransmitted by the energy-transmission device from a first form into asecond form of energy.

According to an embodiment, said energy-transforming device directlypowers implantable energy consuming components of the apparatus with thesecond form energy, as the energy-transforming device transforms thefirst form energy transmitted by the energy-transmission device into thesecond form energy.

According to an embodiment, said second form energy comprises at leastone of a direct current, pulsating direct current and an alternatingcurrent.

According to yet another embodiment, said system further comprises animplantable accumulator, wherein the second form energy is used at leastpartly to charge the accumulator.

According to an embodiment, said energy of the first or second formcomprises at least one of magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy thermal energy, non-magnetic energy, non-kinetic energy,non-chemical energy, non-sonic energy, non-nuclear energy andnon-thermal energy.

According to yet another embodiment, said system further comprisesimplantable electrical components including at least one voltage levelguard and/or at least one constant current guard.

According to yet another embodiment, said system further comprises acontrol device for controlling the transmission of wireless energy fromthe energy-transmission device, and an implantable internal energyreceiver for receiving the transmitted wireless energy, the internalenergy receiver being connected to implantable energy consumingcomponents of the apparatus for directly or indirectly supplyingreceived energy thereto, the system further comprising a determinationdevice adapted to determine an energy balance between the energyreceived by the internal energy receiver and the energy used for theimplantable energy consuming components of the apparatus, wherein thecontrol device controls the transmission of wireless energy from theexternal energy-transmission device, based on the energy balancedetermined by the determination device.

According to an embodiment, said determination device is adapted todetect a change in the energy balance, and the control device controlsthe transmission of wireless energy based on the detected energy balancechange.

According to a further embodiment, the determination device is adaptedto detect a difference between energy received by the internal energyreceiver and energy used for the implantable energy consuming componentsof the apparatus, and the control device controls the transmission ofwireless energy based on the detected energy difference.

According to a further embodiment, the energy-transmission devicecomprises a coil placed externally to the human body, further comprisingan implantable energy receiver to be placed internally in the human bodyand an electric circuit connected to power the external coil withelectrical pulses to transmit the wireless energy, the electrical pulseshaving leading and trailing edges, the electric circuit adapted to varyfirst time intervals between successive leading and trailing edgesand/or second time intervals between successive trailing and leadingedges of the electrical pulses to vary the power of the transmittedwireless energy, the energy receiver receiving the transmitted wirelessenergy having a varied power.

According to a further embodiment, the electric circuit is adapted todeliver the electrical pulses to remain unchanged except varying thefirst and/or second time intervals.

According to a further embodiment, the electric circuit has a timeconstant and is adapted to vary the first and second time intervals onlyin the range of the first time constant, so that when the lengths of thefirst and/or second time intervals are varied, the transmitted powerover the coil is varied.

According to a further embodiment, the system comprises an implantableinternal energy receiver for receiving wireless energy, the energyreceiver having an internal first coil and a first electronic circuitconnected to the first coil, and an external energy transmitter fortransmitting wireless energy, the energy transmitter having an externalsecond coil and a second electronic circuit connected to the secondcoil, wherein the external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver, the system further comprising a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off.

According to a further embodiment, the system comprises an implantableinternal energy receiver for receiving wireless energy, the energyreceiver having an internal first coil and a first electronic circuitconnected to the first coil, and an external energy transmitter fortransmitting wireless energy, the energy transmitter having an externalsecond coil and a second electronic circuit connected to the secondcoil, wherein the external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver, the system further comprising a feedback device forcommunicating out the amount of energy received in the first coil as afeedback information, and wherein the second electronic circuit includesa determination device for receiving the feedback information and forcomparing the amount of transferred energy by the second coil with thefeedback information related to the amount of energy received in thefirst coil to obtain the coupling factors between the first and secondcoils.

According to an embodiment, the transmitted energy may be regulateddepending on the obtained coupling factor.

According to a further embodiment, said external second coil is adaptedto be moved in relation to the internal first coil to establish theoptimal placement of the second coil, in which the coupling factor ismaximized.

According to a further embodiment, said external second coil is adaptedto calibrate the amount of transferred energy to achieve the feedbackinformation in the determination device, before the coupling factor ismaximized.

According to yet another embodiment, the mechanical device comprises amechanical multi step locking mechanism, locking the mechanical devicein its new position after adjustment. An example is illustrated in FIG.10 where FIG. 10a shows schematically a detail view of a device (700)according to the invention, said device comprising at least onehydraulic piston (701) and two actuators (702, 703). In this embodimentone actuator is attached to the housing of the device, whereas the otheris moving. In order to prevent an actuator from returning to a previousposition, for example when temporarily subjected to an increased stress,the housing has an aperture (705) and the actuator has cone-shapedflanges (704) allowing an outward movement of the actuator, butsubstantially preventing an inward movement.

FIG. 10b shows an alternative embodiment where, in a device (800)according to the invention, two pistons (801, 802) are provided in ahousing. The pistons are connected to two actuators (805, 806), which inturn are engaged to anchoring devices (not shown). On the inside, saidhousing has a pattern of protrusions, velts or barbs, allowing saidpistons to move in one direction, preferably outward, but substantiallypreventing an inward movement.

According to yet another embodiment, the mechanical multi step lockingmechanism comprises at least one of a sprint, a elongated structureusing the principle of saw teeth, flanges, barbs or a bonnet band, anut, a gearbox, or a spring loaded locking principle.

According to a further embodiment of the system, the device comprises acontrol device.

According to another embodiment, said control device follows a programof incremental changes, set before the device is implanted.

According to another embodiment, said control device follows a programof incremental changes, communicated to the control device afterimplantation and/or during the treatment.

According to another embodiment, said control device comprises anexternal control unit and an implantable receiver suitable for wirelesscommunication with said external control unit, having a transmitterlocated outside the body.

According to another embodiment, said control device controlsincremental changes of the adjustment device, communicated to thereceiver after implantation and/or during the treatment by using saidexternal control unit.

According to a preferred embodiment, said device is flexible to allowintroduction into the medullar cavity. Alternatively or in combinationtherewith, said device is at least partly elastic. Alternatively or incombination therewith, said device comprises a spring. Alternatively orin combination therewith, said device is adapted to regain its shapeafter having been bent.

According to another embodiment, freely combinable with the otherembodiments presented herein, the anchoring device comprises a threadfor engaging and stabilizing the anchoring device in relation to thebone.

According to a further embodiment, the anchoring device comprises anexpandable part expanding at least partially perpendicular to thelongitudinal extension of the elongated device for engaging andstabilizing the anchoring device in relation to the bone. Thisembodiment is illustrated in FIG. 33, which schematically shows a device900, having two end-portions or anchoring means 902 and 903, for exampleelastic and expandable means, here shown as activated externally, by akey or knob 901, having a portion insertable into the device 900 andengaging a mechanism activating and in particular expanding theanchoring means 902 and 903.

The views I, II and III show in turn how the anchoring means 902 and 903are in their initial, non-expanded state, allowing insertion into acavity; how they can be activated and expanded; and how they whenexpanded engage the surrounding cavity and allow the operation of thedevice for bone adjustment.

According to an alternative embodiment, schematically shown in FIG. 34,a device 920 comprises anchoring means in the form of an arrangement offlanges 922 and 923. An external device, here shown as a wire 921 havingan end portion capable of engaging a mechanism for activation of 922 and923, is brought in operational contact with the device, and theanchoring devices activated. When activate, the anchoring devices engagethe surrounding cavity and allow the operation of the device for boneadjustment.

FIG. 38 shows a partial cut-out view of a bone 1020 having a fracturezone 1021, with an implantable device according to an embodiment of theinvention implanted in the medullar cavity 1040, said device comprisinga body 1030 and two anchoring devices 1050 and 1051. The entry hole 1022is shown as sealed or closed, for example with bone cement, and theadjustment device is shown in extended and operational condition, wherethe anchoring devices 1050 and 1051 securely engage the bone.

According to a further embodiment, the adjustment device is adapted tocomprise torsion of a bone. Alternatively, or in combination, saidadjustment device is adapted to change the angle of a bone.

According to a further embodiment, said adjustment device comprises atleast two parts, wherein the parts are adapted to rotate in relation toeach other. Preferably said relative rotation is anchored by said atleast two anchoring devices.

According to another embodiment, freely combinable with the otherembodiments presented herein, said adjustment device is adapted tochange the angle of a bone.

According to further embodiment, freely combinable with the otherembodiments presented herein, said adjustment device comprises at leasttwo parts, wherein the parts are adapted to be positioned at an angle inrelation to each other.

This is illustrated schematically in FIG. 40 shows an embodiment wherethe implanted adjustment device comprises at least two parts 2100 and2200, wherein the parts are adapted to be positioned at an angle inrelation to each other, and/or rotated in relation to each other. Themovement is achieved by the provision of a joint, here shown as asemicircular or hemispherical element 2250, attached to an operationdevice 2260, adapted to turn or rotate the element 2250 in relation tothe part 2200. The element 2250 is also operationally engaged to thepart 2100, where an adjustment device 2150 is adapted to engage saidelement, in order to change the angle between the parts 2100 and 2200.Preferably said operation device 2260 and said adjustment device 2260each comprise a motor, and optionally also a gear box and a controlunit, as described in the context of other embodiments herein.

The arrows schematically indicate the possible directions of movement ofthe parts shown in FIG. 40, but it is understood that the parts can beangled, tilted or rotated in relation to each other as desired.

According to a further embodiment, said two or more anchoring devicesare adapted to engage and carry weight purely on the inside of the bone.

According to yet another embodiment, said two or more anchoring devicesare adapted to engage with and carry weight to the bone withoutpenetrating to the outside of the bone.

According to yet another embodiment, said two or more anchoring devicesare adapted to engage and carry weight purely on the outside of thebone.

According to another embodiment, freely combinable with any embodimentpresented herein, said device comprises a sensor directly or indirectlysensing the position of the adjustment device.

According to a further embodiment, the device comprises a feedbacktransmitter adapted to transmit information received directly orindirectly from said sensor out from the human body, said transmittedinformation adapted to be received by a external control unit andrelating to the position of the adjustment device.

According to another embodiment of the device, said operation device isa motor operated as a three-phase motor. Alternatively, said operationdevice is a motor operated as a two- or more phase motor.

According to another embodiment, freely combinable with any embodimentpresented herein, said device comprises a gearbox connected to themotor, a motor package, wherein the outgoing speed from the motorpackage is lower than the speed by said motor alone, accomplished bysaid gearbox.

According to another embodiment, freely combinable with any embodimentpresented herein, said device comprises an electrical speed controllerconnected to the motor, a motor package, wherein the outgoing speed ofthe motor in said motor package is decreased by said electrical speedcontroller.

According to any of the above embodiments, the motor is a rotationalmotor and the outgoing speed of the motor package is decreased to lessthan 100 turns per second, alternatively decreased to less than 10 turnsper second, alternatively to less than 1 turn per second, oralternatively to less than 0.1 turn per second, or alternatively to lessthan 0.01 turn per second, or alternatively to less than 0.001 turn persecond.

According to another embodiment, freely combinable with any embodimentpresented herein, said device comprises an electrical speed controllerconnected to the motor, a motor package, wherein the outgoing speed ofthe motor of said motor package is controlled by said electrical speedcontroller.

According to any of the above embodiments, the motor is a linear motorand the outgoing speed of the motor package is less than 1 mm persecond, alternatively less than 0.1 mm per second, or alternatively lessthan 0.01 mm per second, or alternatively less than 0.001 mm per second,or alternatively less than 0.0001 mm per second, or less than 0.00001 mmper second.

The construction of a device according to the invention is illustratedalso in FIG. 35, schematically showing an embodiment of the device 930,comprising two telescopically arranged parts 932 and 933, housing alongitudinal threaded central shaft or axis 937 and a motor or geararrangement 938 acting thereon, transforming rotational force intolongitudinal force and extension or contraction of the device.

Further, FIG. 36 shows another related embodiment where the devicecomprises three main parts, a central section 935, and twotelescopically arranged end sections 934 and 936, each connected to alongitudinal threaded central shaft or axis 939 and 940 through a motoror gear arrangement 941 and 942.

Finally, FIGS. 37A and B show embodiments where a device for boneadjustment according to the present invention, schematically shown as1000 and 1010, is enclosed in a flexible or elastic outer cover 1001, oran expandable outer cover 1011, where the expansion made possible forexample by folds 1012, said covers protecting the device from directcontact with tissues and body fluids.

Said elastic, flexible or expandable cover is preferably made of apolymeric material generally recognised as safe and approved forsurgical use, and can be suitably coated to minimize tissue irritation.Non-limiting examples of the material include silicon, polyurethane andTEFLON®, and non-limiting examples of suitable coatings include atomizedmetal coatings, and polymeric coatings, such as PARYLENE®.

The inventions also concern a method for bone adjustment in a mammal,wherein a hydraulic or mechanical device according to any of the abovepresented embodiments is used and implanted in the body of said mammal.

According to a further embodiment, said device is implantedintramedullary in the body of said mammal, exerting a force to anchoringdevices anchored to the inside of said bone.

According to a further embodiment, said bone adjustment is thelengthening of a bone, the healing of a fracture, the changing of a boneangle, the reshaping of a bone, or a combination thereof.

According to a further embodiment, said adjustment is a step in atreatment to correct a limb discrepancy caused by a congenitalcondition, deformation or previous trauma.

According to a further embodiment, said adjustment is reshaping orlengthening of a bone involving distraction osteogenesis treatment.

According to a further embodiment, said adjustment is the reshaping orlengthening of a bone as a step of correcting a congenital deformation.

According to a further embodiment, said adjustment is the reshaping orlengthening of a bone as a step of a cosmetic treatment.

According to another embodiment of the method, freely combinable withany of the embodiments presented herein, reshaping is one of changingthe angle or curvature of a bone, changing the torsion of a bone,changing the angle between the diaphysis and the epiphysis, changing thethickness of a bone or a combination thereof.

According to another embodiment a device is implanted intramedullary inthe body of said mammal, wherein said device is a hydraulic deviceexerting a force to anchoring devices anchored in said bone and acontrol device which controls the amount of force exerted by the device.

According to another embodiment a device is implanted intramedullary inthe body of said mammal, wherein said device is a mechanical deviceexerting a force to anchoring devices anchored in said bone and acontrol device which controls the amount of force exerted by the device.

According to another embodiment of the method, freely combinable withany of the embodiments presented herein, said control device follows aprogram of incremental changes, set before the device is implanted.Alternatively, said control device follows a program of incrementalchanges, communicated to the control device after implantation and/orduring the treatment.

According to another embodiment of the method, freely combinable withany of the embodiments presented herein, the device is stabilized whenthe treatment is completed.

According to an embodiment, said device is stabilized by filling thedevice with a material which stabilizes the position of the adjustmentdevice and permanents the distance between the anchoring devices.Preferably said material is chosen from a curable foam, a curable gel, apolymer or polymer mixture which solidifies, crosslinks or otherwiseattains and retains a stable volume.

According to another embodiment said device is a hydraulic device andthe hydraulic fluid is a material chosen from a curable foam, a curablegel, a polymer or polymer mixture which solidifies, crosslinks orotherwise attains and retains a stable volume when the curing,solidification, crosslinking or other reaction is initiated by the user.

According to another embodiment, the device is a hydraulic device and amaterial chosen from curable foam, a curable gel, a polymer or polymermixture which solidifies, crosslinks or otherwise attains and retains astable volume, is added to said device, partially or completelyreplacing the hydraulic fluid.

Another embodiment comprises a method for distractive osteogenesis wherethe fractured bone is subjected to an intermittent and/or oscillatingforce using an implanted hydraulic or mechanical device.

Another embodiment is a method for treating a bone dysfunction of amammal patient by providing a device for bone adjustment comprising atleast two anchoring devices according to any of the embodimentspresented herein, the method comprising the steps of

-   -   i. inserting a needle or tube-like instrument into a cavity of        said mammal patient;    -   ii. inflating said cavity by introducing a fluid through said        needle or tube-like instrument and thereby expanding said        cavity;    -   iii. placing at least two laparoscopic trocars in said cavity;    -   iv. inserting a camera through one of said laparoscopic trocars        into said cavity;    -   v. inserting at least one dissecting tool through one of said at        least two laparoscopic trocars;    -   vi. dissecting an area of the dysfunctional bone;    -   vii. placing the device for bone adjustment and anchoring        devices in the medullar cavity of said bone;    -   viii. anchoring said anchoring devices in contact with said        bone;    -   ix. closing the mammal body preferably in layers; and    -   x. non-invasively adjusting said bone postoperatively.

Another embodiment is method of treating a bone dysfunction of a mammalpatient by providing a device for bone adjustment comprising at leasttwo anchoring devices according to any of the embodiments presentedherein, comprising the steps of:

-   -   i. cutting the skin of said human patient;    -   ii. dissecting an area of the dysfunctional bone;    -   iii. placing the device in the medullar cavity of said bone;    -   iv. anchoring said anchoring devices in contact with said bone;    -   v. closing the mammal body preferably in layers; and    -   vi. non-invasively adjusting said bone postoperatively.

The method according to any of the above embodiments preferablycomprises the step of withdrawing the instruments.

The method according to any of the above embodiments preferablycomprises the step of closing the skin using sutures or staples.

According to a further embodiment of the method, the step of dissectingincludes dissecting an area of the arm or leg comprising, dissecting anarea of at least one of the following bones; clavicula, scapula,humerus, radius, ulna, pelvic bone, femur, tibia, fibula or calcaneus.

According to a further embodiment of the method, the step of dissectingincludes dissecting an area of the arm or leg comprising, dissecting anarea at least one of the following joints; shoulder, elbow, hip, knee,hand and foot.

According to a further embodiment of the method, an opening into themedullar cavity is made by drilling.

The inventions also concern a system comprising an apparatus accordingto any one of the embodiments presented herein.

According to a further embodiment of the system, said system comprisesat least one switch implantable in the patient for manually andnon-invasively controlling the apparatus.

According to another embodiment, said system further comprises ahydraulic device having an implantable hydraulic reservoir, which ishydraulically connected to the apparatus, wherein the apparatus isadapted to be non-invasively regulated by manually pressing thehydraulic reservoir.

According to another embodiment, said system further comprises awireless remote control for non-invasively controlling the apparatus.

According to another embodiment, the wireless remote control comprisesat least one external signal transmitter and/or receiver, furthercomprising an internal signal receiver and/or transmitter implantable inthe patient for receiving signals transmitted by the external signaltransmitter or transmitting signals to the external signal receiver.

According to another embodiment, said wireless remote control transmitsat least one wireless control signal for controlling the apparatus.

According to another embodiment, said wireless control signal comprisesa frequency, amplitude, or phase modulated signal or a combinationthereof.

According to another embodiment, said wireless remote control transmitsan electromagnetic carrier wave signal for carrying the control signal.

According to another embodiment, said system further comprises awireless energy-transmission device for non-invasively energizingimplantable energy consuming components of the apparatus with wirelessenergy.

According to another embodiment, said wireless energy comprises a wavesignal selected from the following: a sound wave signal, an ultrasoundwave signal, an electromagnetic wave signal, an infrared light signal, avisible light signal, an ultra violet light signal, a laser lightsignal, a micro wave signal, a radio wave signal, an x-ray radiationsignal and a gamma radiation signal.

According to another embodiment, said wireless energy comprises one ofthe following: an electric field, a magnetic field, a combined electricand magnetic field.

According to another embodiment, said control signal comprises one ofthe following: an electric field, a magnetic field, a combined electricand magnetic field.

According to another embodiment, said signal comprises an analoguesignal, a digital signal, or a combination of an analogue and digitalsignal.

According to another embodiment, said system further comprises animplantable internal energy source for powering implantable energyconsuming components of the apparatus.

According to another embodiment, said system further comprises anexternal energy source for transferring energy in a wireless mode,wherein the internal energy source is chargeable by the energytransferred in the wireless mode.

According to another embodiment, said system further comprises a sensoror measuring device sensing or measuring a functional parametercorrelated to the transfer of energy for charging the internal energysource, and a feedback device for sending feedback information frominside the patient's body to the outside thereof, the feedbackinformation being related to the functional parameter sensed by thesensor or measured by the measuring device.

According to another embodiment, said system further comprises afeedback device for sending feedback information from inside thepatient's body to the outside thereof, the feedback information beingrelated to at least one of a physical parameter of the patient and afunctional parameter related to the apparatus.

According to another embodiment, said system further comprises a sensorand/or a measuring device and an implantable internal control unit forcontrolling the apparatus in response to information being related to atleast one of a physical parameter of the patient sensed by the sensor ormeasured by the measuring device and a functional parameter related tothe apparatus sensed by the sensor or measured by the measuring device.Said physical parameter is preferably a pressure or a motility movement.

According to another embodiment, said system further comprises anexternal data communicator and an implantable internal data communicatorcommunicating with the external data communicator, wherein the internalcommunicator feeds data related to the apparatus or the patient to theexternal data communicator and/or the external data communicator feedsdata to the internal data communicator.

According to another embodiment, said system further comprises a motoror a pump for operating the apparatus.

According to another embodiment, said system further comprises ahydraulic operation device for operating the apparatus.

According to another embodiment, said system further comprises anoperation device for operating the apparatus, wherein the operationdevice comprises a servo or mechanical amplifier designed to decreasethe force needed for the operation device to operate the apparatusinstead the operation device acting a longer way, increasing the timefor a determined action.

According to another embodiment, said system further comprises anoperation device for operating the apparatus, wherein the wirelessenergy is used in its wireless state to directly power the operationdevice to create kinetic energy for the operation of the apparatus, asthe wireless energy is being transmitted by the energy-transmissiondevice.

According to another embodiment, said system further comprises anenergy-transforming device for transforming the wireless energytransmitted by the energy-transmission device from a first form into asecond form of energy.

According to an embodiment said energy-transforming device directlypowers implantable energy consuming components of the apparatus with thesecond form energy, as the energy-transforming device transforms thefirst form energy transmitted by the energy-transmission device into thesecond form energy.

According to an embodiment said second form energy comprises at leastone of a direct current, pulsating direct current and an alternatingcurrent.

According to another embodiment, said system further comprises animplantable accumulator, wherein the second form energy is used at leastpartly to charge the accumulator.

According to an embodiment, freely combinable with any of theembodiments presented herein, said energy of the first or second formcomprises at least one of magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy thermal energy, non-magnetic energy, non-kinetic energy,non-chemical energy, non-sonic energy, non-nuclear energy andnon-thermal energy.

According to another embodiment, said system further comprisesimplantable electrical components including at least one voltage levelguard and/or at least one constant current guard.

According to another embodiment, said system further comprises a controldevice for controlling the transmission of wireless energy from theenergy-transmission device, and an implantable internal energy receiverfor receiving the transmitted wireless energy, the internal energyreceiver being connected to implantable energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto, the system further comprising a determination device adapted todetermine an energy balance between the energy received by the internalenergy receiver and the energy used for the implantable energy consumingcomponents of the apparatus, wherein the control device controls thetransmission of wireless energy from the external energy-transmissiondevice, based on the energy balance determined by the determinationdevice.

According to an embodiment, said determination device is adapted todetect a change in the energy balance, and the control device controlsthe transmission of wireless energy based on the detected energy balancechange.

According to another embodiment, said determination device is adapted todetect a difference between energy received by the internal energyreceiver and energy used for the implantable energy consuming componentsof the apparatus, and the control device controls the transmission ofwireless energy based on the detected energy difference.

According to another embodiment, said energy-transmission devicecomprises a coil placed externally to the human body, further comprisingan implantable energy receiver to be placed internally in the human bodyand an electric circuit connected to power the external coil withelectrical pulses to transmit the wireless energy, the electrical pulseshaving leading and trailing edges, the electric circuit adapted to varyfirst time intervals between successive leading and trailing edgesand/or second time intervals between successive trailing and leadingedges of the electrical pulses to vary the power of the transmittedwireless energy, the energy receiver receiving the transmitted wirelessenergy having a varied power.

According to another embodiment, said electric circuit is adapted todeliver the electrical pulses to remain unchanged except varying thefirst and/or second time intervals.

According to another embodiment, said the electric circuit has a timeconstant and is adapted to vary the first and second time intervals onlyin the range of the first time constant, so that when the lengths of thefirst and/or second time intervals are varied, the transmitted powerover the coil is varied.

According to another embodiment, said system further comprises animplantable internal energy receiver for receiving wireless energy, theenergy receiver having an internal first coil and a first electroniccircuit connected to the first coil, and an external energy transmitterfor transmitting wireless energy, the energy transmitter having anexternal second coil and a second electronic circuit connected to thesecond coil, wherein the external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver, the system further comprising a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off.

According to another embodiment, said system further comprises animplantable internal energy receiver for receiving wireless energy, theenergy receiver having an internal first coil and a first electroniccircuit connected to the first coil, and an external energy transmitterfor transmitting wireless energy, the energy transmitter having anexternal second coil and a second electronic circuit connected to thesecond coil, wherein the external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver, the system further comprising a feedback device forcommunicating out the amount of energy received in the first coil as afeedback information, and wherein the second electronic circuit includesa determination device for receiving the feedback information and forcomparing the amount of transferred energy by the second coil with thefeedback information related to the amount of energy received in thefirst coil to obtain the coupling factors between the first and secondcoils.

According to another embodiment, said transmitted energy may beregulated depending on the obtained coupling factor.

According to another embodiment, said external second coil is adapted tobe moved in relation to the internal first coil to establish the optimalplacement of the second coil, in which the coupling factor is maximized.

According to another embodiment, said external second coil is adapted tocalibrate the amount of transferred energy to achieve the feedbackinformation in the determination device, before the coupling factor ismaximized.

According to another embodiment, said mechanical device comprises amechanical multi step locking mechanism, locking the mechanical devicein its new position after adjustment.

According to a further embodiment, said mechanical multi step lockingmechanism comprises at least one of a sprint, a elongated structureusing the principle of saw teeth, flanges, barbs or a bonnet band, anut, a gearbox, or a spring loaded locking principle.

According to an embodiment, said hydraulic adjustment device is adaptedto being stabilized when the bone adjustment is completed.

According to an embodiment, said hydraulic adjustment device can befilled with a material which stabilizes the position of the adjustmentdevice and permanents the distance between the anchoring devices.

In the above embodiment, said material is preferably chosen from curablefoam, a curable gel, a polymer or polymer mixture which solidifies,crosslinks or otherwise attains and retains a stable volume.

According to an embodiment, said hydraulic fluid used in said device isa material chosen from a curable foam, a curable gel, a polymer orpolymer mixture which solidifies, crosslinks or otherwise attains andretains a stable volume when the curing, solidification, crosslinking orother reaction is initiated by the user.

In the above embodiment, the material chosen from a curable foam, acurable gel, a polymer or polymer mixture which solidifies, crosslinksor otherwise attains and retains a stable volume, is added to thedevice, partially or completely replacing the hydraulic fluid.

According to another embodiment, said device comprises a control device.Said control device preferably follows a program of incremental changes,set before the device is implanted. Alternatively, said control devicefollows a program of incremental changes, communicated to the controldevice after implantation and/or during the treatment.

According to an embodiment, said control device comprises an externalcontrol unit and an implantable receiver suitable for wirelesscommunication with said external control unit, having a transmitterlocated outside the body.

According to another embodiment, said control device controlsincremental changes of the adjustment device, communicated to thereceiver after implantation and/or during the treatment by using saidexternal control unit.

According to another embodiment, freely combinable with any otherembodiment presented herein, said adjustment device is adapted to adjusttorsion of a bone.

According to another embodiment, said adjustment device is adapted tochange the angle of a bone.

According to another embodiment, said adjustment device comprises atleast two parts, wherein the parts is adapted to rotate in relation toeach other.

According to another embodiment, said relative rotation is anchored bysaid at least two anchoring devices.

According to another embodiment, said adjustment device comprises atleast two parts, wherein the parts is adapted to be angled in relationto each other.

According to another embodiment, said adjustment device is adapted tochange the curvature of a bone including the spinal column.

According to another embodiment, said adjustment device is adapted torealign or reposition a joint or a vertebra including the reforming orsupporting the shape of the spinal column.

According to another embodiment, two or more anchoring devices areadapted to engage and carry weight purely on the outside of the bone.

According to another embodiment of the device, said two or moreanchoring devices are adapted to engage with and carry weight to thebone without penetrating to the inside of the bone, the medulla of thebone.

According to another embodiment, said adjustment device is adapted to beplaced on the outside of the bone.

According to yet another embodiment, said device comprises a sensordirect or indirect sensing the position of the adjustment device.

According to yet another embodiment, said device comprises a feedbacktransmitter adapted to transmit information received direct or indirectfrom said sensor out from the human body, said transmitted informationadapted to be received by a external control unit and relating to theposition of the adjustment device.

According to an embodiment, said operation device is a motor operated asa three-phase motor. Alternatively, said operation device is a motoroperated as a two- or more phase motor.

According to yet another embodiment, said device comprises a gearboxconnected to the motor, a motor package, wherein the outgoing speed fromthe motor package is lower than the speed by said motor alone,accomplished by said gearbox.

According to a further embodiment, said outgoing speed of the motor insaid motor package is decreased by said electrical speed controller.

According to an embodiment, said motor is a rotational motor and theoutgoing speed of the motor package is decreased to less than 100 turnsper second, or decreased to less than 10 turns per second, or to lessthan 1 turn per second, or to less than 0.1 turn per second, or to lessthan 0.01 turn per second, or to less than 0.001 turn per second.

According to yet another embodiment, said device comprises an electricalspeed controller connected to the motor, a motor package, wherein theoutgoing speed of the motor in said motor package is controlled by saidelectrical speed controller.

According to an embodiment, said motor is a linear motor and theoutgoing speed of the motor package is less than 1 mm per second, orless than 0.1 mm per second, or less than 0.01 mm per second, or lessthan 0.001 mm per second, or less than 0.0001 mm per second, or lessthan 0.00001 mm per second.

It should be noted that the above embodiments, and features appearing inthe individual embodiments, are freely combinable.

EXAMPLES

There are animal models for the investigation of fracture healing, suchas a rabbit fibula model, a sheep model for fracture treatment inosteoporosis, a murine femur fracture model. It is conceived that theinventive device and method can be tested in existing animal models,preferably models involving the use of larger mammals, such as sheep,pig, dog, monkey etc.

There are also non-invasive methods for the evaluation of bone fracturehealing, see e.g. a review article (Protopappas et al., 2008) describingquantitative ultrasonic monitoring of bone fracture healing.

In a suitable animal model, a test animal is anaesthetised, and a bonedissected and fractured. When dissecting a bone, care is taken to causeminimal tissue damage, e.g. by folding or pulling tissue to the sideinstead of removing it from its location. Pins or other anchoringdevices are fixed in the bone on both sides of the fracture, and adevice according to the invention attached to said anchoring devices.The tissue is replaced carefully, preferably layer by layer, and thebody of the animal closed. After a suitable initial healing period, thefracture zone is adjusted non-invasively. Parameters such as bonehealing, pain and signs of infection or inflammation are observedregularly. Following euthanasia, the bone is dissected and the fracturezone analysed.

The experiment can be repeated, with necessary modifications, in thesame or in a different animal model, for evaluating the adjustment ofthe curvature of the spine, realigning a joint, changing the curvatureof a bone, or the like.

Although the invention has been described with regard to its preferredembodiments, which constitute the best mode presently known to theinventors, it should be understood that various changes andmodifications as would be obvious to one having the ordinary skill inthis art may be made without departing from the scope of the inventionwhich is set forth in the claims appended hereto.

REFERENCES

Consolo U, Bertoldi C, Zaffe D, Intermittent loading improves results inmandibular alveolar distraction osteogenesis, Clin Oral Implants Res.2006 April; 17(2):179-87.

Gabbay J S, Zuk P A, Tahernia A, Askari M, O'Hara C M, Karthikeyan T,Azari K, Hollinger J O, Bradley J P, In vitro microdistraction ofpreosteoblasts: distraction promotes proliferation and oscillationpromotes differentiation, Tissue Eng. 2006 November; 12(11):3055-65.

Hente R, Füchtmeier B, Schlegel U, Ernstberger A, Perren S M., Theinfluence of cyclic compression and distraction on the healing ofexperimental tibial fractures. J Orthop Res., 2004 July; 22(4):709-15

Protopappas V C, Vavva M G, Fotiadis D I, Malizos K N, IEEE TransUltrason Ferroelectr Freq Control. 2008; 55(6):1243-55

Snela S, Kisiel J, Gregosiewicz A, Dziubiński F., Biomechanical studiesof forces occurring in the Ilizarov and Orthofix apparatuses during limblengthening by distractive osteogenesis, Chir Narzadow Ruchu Ortop Pol.2000; 65(2):155-66. [Article in Polish]

The invention claimed is:
 1. An implantable device for the elongation ofa bone in a mammal, comprising: at least one elongated device adapted tobe implanted in relation to said bone, two or more anchoring devicesadapted to be in contact with the bone in said mammal, adapted to engagethe bone and stabilizing in relation to the bone, wherein said anchoringdevices are adapted to be implanted intramedullary in the bone of saidmammal, wherein the two or more anchoring devices are adapted to engagesaid bone from the inside of the intramedullar cavity of the bone andcarry weight on the inside of the bone, and an adjustment device adaptedto be implanted intramedullary in the bone of said mammal, for adjustingat least one mechanical bone related parameter of, said at least oneelongated device, wherein said adjustment device is constructed topostoperatively non-invasively adjust said at least one mechanical bonerelated parameter, and wherein said adjustment device is adapted to atleast adjust the distance between or orientation of the at least twoanchoring devices, wherein said implantable device for the adjustment ofa bone is adapted to be wirelessly powered, directly or indirectly, andadapted to receive wireless energy, non-invasively transmitted from anexternal source for adjusting said at least one mechanical bone relatedparameter by said adjustment device, wherein the implantable devicefurther comprising a feedback device for sending feedback informationfrom inside the patient's body to the outside thereof, the feedbackinformation being related to at least one of a physical parameter of thepatient and a functional parameter related to the implantable device,wherein the feedback information comprises at least information relatingto an amount of energy received in a first coil, when and during thewireless energy being received, and wherein said two or more anchoringdevices are adapted to securely engage the surrounding bone from insidethe medullar cavity, and comprise a part securing and extending at leastpartially perpendicular to the longitudinal extension of the elongateddevice for engaging and stabilizing the anchoring device in relation tothe bone.
 2. The implantable device according to claim 1, wherein saidat least one mechanical bone related parameter is related to thelengthening of a bone, the shortening of a bone, the healing of afracture, the changing of a bone angle, the rotation of a bone, theadjustment of the curvature or torsion of a bone, the reshaping of abone, the realignment or repositioning of a joint or a vertebra, thereforming or supporting the shape of the spinal column, bringing atleast two bone-parts defining a fracture closer to each other for aperiod of time having a beneficial influence on the initiation of thehealing process, and bringing said at least two bone-parts defining afracture away from each other for a period of time having a beneficialinfluence on the formation of bone, during the healing process, or acombination thereof.
 3. The implantable device according to claim 1,wherein the two or more anchoring device is adapted to be adjustable bysaid adjustment device, when implanted in the mammal, for engaging andstabilizing the anchoring device in relation to the bone.
 4. Theimplantable device according to claim 1, wherein said device comprisingan internal control unit adapted to be at least one of: programmablefrom outside the patient's body, programmed to regulate the implantabledevice according to a pre-programmed time-schedule, and programmed toregulate the implantable device according to input from a sensor sensingany possible physical parameter of the patient or any functionalparameter of the system.
 5. The implantable device according to claim 1,wherein the two or more anchoring devices comprising, at least one of:at least one of a pin, a screw, an adhesive, a barb construction, asaw-tooth construction, an expandable element, combinations thereof orother mechanical connecting members, a thread for engaging andstabilizing the anchoring device in relation to the bone.
 6. Theimplantable device according to claim 1, wherein the adjustment deviceadjust the force exerted by the adjustment device, wherein the force is,at least one of; a longitudinal force, extending the length of the bone,a force directed to the end portions of the medullar cavity, alongitudinal force, adjusting the angle or curvature of the bone, and aforce applying torque to the bone, adjusting the torsion of the bonealong it's longitudinal axis.
 7. The implantable device according toclaim 1, wherein said adjustment device is at least one of: adapted tocomprise torsion of a bone, adapted to change the angle of a bone,adapted to have at least two parts to rotate in relation to each other,wherein said adjustment device comprises at least two parts, adapted tohave at least two parts to rotate in relation to each other, whereinsaid adjustment device comprises at least two parts, the relativerotation being anchored by at least two anchoring devices, adapted tohave at least two parts angled in relation to each other, wherein saidadjustment device comprises at least two parts, adapted to change thecurvature of a bone including the spinal column, adapted to realign orreposition a joint or a vertebra including the reforming or supportingthe shape of the spinal column, and adapted to be placed on the outsideof the bone.
 8. The implantable device according to claim 1, wherein thedevice comprises a control device, which is at least one of: adapted tofollows a program of incremental changes, set before the device isimplanted, adapted to follow a program of incremental changes,communicated to the control device after implantation and/or during thetreatment, adapted to control incremental changes of the adjustmentdevice, communicated to the receiver after implantation and/or duringthe treatment by using an external control unit, and adapted to regulatethe device non-invasively by manually pressing at least one subcutaneousswitch, whereby the operation of the device is switched on and off. 9.The implantable device according to claim 1, wherein the devicecomprises a control device, comprising at least one of: an externalcontrol unit and an implantable receiver suitable for wirelesscommunication with said external control unit, having a transmitterlocated outside the body, and an internal control unit adapted toregulate the device non-invasively by manually pressing at least onesubcutaneous switch, wherein the switch sends information to theinternal control unit to perform a certain predetermined performance.10. The implantable device according to claim 1, wherein the adjustmentdevice comprising a mechanical device for said bone adjustment which isat least one of: comprising an operation device which comprises a motor,comprising a device positioning system such as a tachometer or any othersensor input to see the position of the adjustment device, comprising acontrol device, wherein an operation device is controlled by the controldevice, comprising at least one nut and screw, comprising at least onegearbox, comprising a servo mechanism or mechanical amplifier,comprising a mechanical multi step locking mechanism, adapted to lockthe mechanical device in its new position after adjustment, andcomprising a mechanical multi step locking mechanism, comprising atleast one of; a sprint, a elongated structure using the principle of sawteeth, flanges, barbs or a bonnet band, a nut, a gearbox, or a springloaded locking principle, adapted to lock the mechanical device in a newposition after adjustment.
 11. The implantable device according to claim1, comprising an operation device, wherein the adjustment device isoperated by the operation device, wherein the operation devicecomprising, at least one of: a motor operated as a three-phase motor, amotor operated as a two or more phase motor, a motor comprising a motoror device positioning system such as a tachometer or any other sensorinput to see the position of the adjustment device, a servo ormechanical amplifier designed to decrease the force needed for theoperation device to operate the adjustment device, instead the operationdevice acting a longer way, increasing the time for a determined action,and the device further comprising at least one of: a gearbox connectedto the motor, a motor package, wherein the outgoing speed from the motorpackage is lower than the speed by said motor alone, accomplished bysaid gearbox, and an electrical speed controller connected to the motor,a motor package, wherein the outgoing speed of the motor in said motorpackage is decreased by said electrical speed controller, wherein themotor package includes at least one of: a rotational motor and theoutgoing speed of the motor package is decreased to at least one of:less than 100 turns per second, less than 10 turns per second, less than1 turn per second, less than 0.1 turn per second, less than 0.01 turnper second, and less than 0.001 turn per second, and a linear motor andthe outgoing speed of the motor package is at least one of: less than 1mm per second, less than 0.1 mm per second, less than 0.01 mm persecond, less than 0.001 mm per second, less than 0.0001 mm per second,and less than 0.00001 mm per second.
 12. The implantable deviceaccording to claim 1, wherein said device is, at least one of:comprising a flexible device adapted to allow introduction into themedullar cavity, comprising a at least partly both elastic and flexibledevice adapted to allow introduction into the medullar cavity,comprising a spring to be flexible adapted to allow introduction intothe medullar cavity, comprising a device adapted to regain its shapeafter having been bent, comprising a device adapted for exerting anintermittent, oscillating force, or intermittent and oscillating force,comprising a locking device, adapted to allow extension of the devicebut substantially prevents contraction, and comprising a sensor director indirect sensing the position of the adjustment device.
 13. Theimplantable device according to claim 1, when the device comprising asensor direct or indirect sensing the position of the adjustment device,the device comprising a feedback transmitter adapted to transmitinformation received direct or indirect from said sensor out from thehuman body, said transmitted information adapted to be received by anexternal control unit and relating to the position of the adjustmentdevice.
 14. The implantable device according to claim 1, adapted to bepart of a system comprising at least one of: a sensor or measuringdevice sensing or measuring a functional parameter correlated to thetransfer of energy for charging an internal energy source, and afeedback device for sending feedback information from inside thepatient's body to the outside thereof, the feedback information beingrelated to the functional parameter sensed by the sensor or measured bythe measuring device, further comprising an implantable internal energysource for powering implantable energy consuming components of theimplantable device, and an external energy source for transferringenergy in a wireless mode, wherein the internal energy source ischargeable by the energy transferred in the wireless mode, a feedbackdevice for sending feedback information from inside the patient's bodyto the outside thereof, the feedback information being related to atleast one of a physical parameter of the patient and a functionalparameter related to the implantable device, a sensor and/or a measuringdevice and an implantable internal control unit for controlling theimplantable device in response to information being related to at leastone of a physical parameter of the patient sensed by the sensor ormeasured by the measuring device and a functional parameter related tothe implantable device sensed by the sensor or measured by the measuringdevice, and an external data communicator and an implantable internaldata communicator communicating with the external data communicator,wherein the internal communicator feeds data related to the implantabledevice or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.15. The implantable device according to claim 1, adapted to be part of asystem comprising at least one of: at least one switch implantable inthe patient for manually and non-invasively controlling the implantabledevice, a wireless remote control for non-invasively controlling theimplantable device, and a hydraulic device having an implantablehydraulic reservoir, which is hydraulically connected to the implantabledevice, wherein the implantable device is adapted to be non-invasivelyregulated by manually pressing the hydraulic reservoir.
 16. Theimplantable device according to claim 1, adapted to be part of a systemcomprising at least one of: a wireless energy-transmission device fornon-invasively energizing implantable energy consuming components of theimplantable device with wireless energy, an implantable internal energysource for powering implantable energy consuming components of theimplantable device, an external energy source for transferring energy ina wireless mode and an implantable internal energy source for poweringimplantable energy consuming components of the implantable device,wherein the internal energy source is chargeable by the energytransferred in the wireless mode, implantable electrical componentsincluding at least one voltage level guard and/or at least one constantcurrent guard, an energy-transforming device for transforming thewireless energy transmitted by tan energy-transmission device from afirst form into a second form of energy, wherein the second form energyis used at least partly to charge an accumulator, an operation devicefor operating the implantable device, wherein the wireless energy isused in its wireless state to directly power the operation device tocreate kinetic energy for the operation of the implantable device, asthe wireless energy is being transmitted by the energy-transmissiondevice, an energy-transforming device for transforming the wirelessenergy transmitted by the energy-transmission device from a first forminto a second form of energy, wherein the energy-transforming devicedirectly powers implantable energy consuming components of theimplantable device with the second form energy, as theenergy-transforming device transforms the first form energy transmittedby the energy-transmission device into the second form energy, and afeedback device for sending feedback information from inside thepatient's body to the outside thereof, the feedback information beingrelated to at least one of a physical parameter of the patient and afunctional parameter related to the implantable device.
 17. Theimplantable device according to claim 1, adapted to be part of a systemcomprising at least one of: a) a wireless energy-transmission device fornon-invasively energizing implantable energy consuming components of theimplantable device with wireless energy, a control device forcontrolling the transmission of wireless energy from theenergy-transmission device, and an implantable internal energy receiverfor receiving the transmitted wireless energy, the internal energyreceiver being connected to implantable energy consuming components ofthe implantable device for directly or indirectly supplying receivedenergy thereto, a determination device adapted to determine an energybalance between the energy received by the internal energy receiver andthe energy used for the implantable energy consuming components of theimplantable device, wherein the control device controls the transmissionof wireless energy from the external energy-transmission device, basedon the energy balance determined by the determination device, and b) animplantable internal energy receiver for receiving wireless energy, theenergy receiver having an internal first coil and a first electroniccircuit connected to the first coil, an external energy transmitter fortransmitting wireless energy, the energy transmitter having an externalsecond coil and a second electronic circuit connected to the secondcoil, wherein the external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver, a feedback device for communicating out the amount ofenergy received in the first coil as a feedback information, and whereinthe second electronic circuit includes a determination device forreceiving the feedback information and for comparing the amount oftransferred energy by the second coil with the feedback informationrelated to the amount of energy received in the first coil to obtain thecoupling factors between the first and second coils.
 18. The implantabledevice according to claim 1, wherein the two or more anchoring devicesare adapted to engage with and carrying weight to the bone withoutpenetrating to the outside of the bone, from the intramedullary cavityof the bone.
 19. The implantable device according to claim 1, whereinthe motor is a rotational motor and the outgoing speed of the motorpackage is decreased to less than: 0.1 turn per second, 0.01 turn persecond, or 0.001 turn per second.
 20. The implantable device accordingto claim 1, comprising a control device, wherein the device is adaptedto be exerting an intermittent, oscillating force, or intermittent andoscillating force according to a preset program or according toinstructions transmitted wirelessly to the control device.
 21. Theimplantable device according to claim 1, wherein the two or moreanchoring devices are adapted to at least anchor a relative rotation ofthe adjustment device from the inside of the bone.
 22. The implantabledevice according to claim 1, wherein the part securing and extending atleast partially perpendicular to the longitudinal extension of theelongated device comprises an expandable part or portion expanding atleast partially perpendicular to the longitudinal extension of theelongated device.
 23. The implantable device according to claim 22,wherein said at least two anchoring devices comprises an anchoringadjustment device adapted to expand said expandable part or portion. 24.The implantable device according to claim 1, wherein said at least twoanchoring devices anchor the device by preventing movements in twodifferent longitudinal directions.